[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS

[TimaaaaaaaahRocks]

Trust?  For a company that has already been shown to have deliberately delayed announcing and withholding an immediate "fix" to a known harmful design flaw (short-term or long-term, serious or minor), is at-best disrespectful - and at worst, criminal.  It's becoming so common today to get ahead of something bad by insisting the exact opposite.  

June 14, 2021: 'out of an abundance of caution' - an overly abused phrase which is shorthand for 'we screwed up so bad even WE can't ignore it anymore'. Like Philips/Respironics is burning north of $2B just to be cautious or out of pure altruism?

• Philips is initiating a voluntary recall notification* to ensure patient safety in consultation with regulatory agencies.
  *This is a recall notification for the US only, and a field safety notice for the rest of the world.

[ST Dog]

Yessir. Any failure with "Low probability but with high consequence" should be red flagged by a properly performed risk analysis and never marketed.
...

Failure Mode: Adhesive does not hold the capacitor bracket in place.  (adhesive? for real? just a fancy name for glue. they used glue to mount a critical component! I reckon bailing wire, chewing gum, or duct tape were all too expensive.)

I work with safety analyses every day. The point is to reduce the probability of such a fault to a certain level. I work with aircraft and conditions with catastrophic consequences have to occur at less than 1 per 10^9 flight hours. But it's not 0 or impossible.

By your standard cars wouldn't be marketed. There are a hundred of different faults that could cause death in operation, but the probability of one occuring is very low.

As for adhesives, they are more that just "glue." From holding wounds closed to holding buildings together, they point is using the correct one for the task. You'd be amazed at all the different adhesives used on aircraft smd what they hold together.

[TimaaaaaaaahRocks]

I work with safety analyses every day. The point is to reduce the probability of such a fault to a certain level. I work with aircraft and conditions with catastrophic consequences have to occur at less than 1 per 10^9 flight hours. But it's not 0 or impossible.

389 ventilator failures thus far from a population of 105,000 units. 1 per 270 units is an unacceptable probability for a failure that can have grave consequences to the patient.

[ST Dog]

389 ventilator failures thus far from a population of 105,000 units. 1 per 270 units is an unacceptable probability for a failure that can have grave consequences to the patient.

Didn't say what they did was right.

You said even with a low probability it should not be marketed. The point being that some risk will always exist. Probability of zero is not possible.

And you metric is wrong. It's not about units it's about hours of use. That's how safety/risk analysis is done. Given enough time all units will fail.

Seems that they chose the wrong adhesive. Why the adhesive fails is an interesting data point. Temperature, humidity, vibration, etc.

But that doesn't concern me as much as the why the alarms don't work with the fault occurs.

[btreger]

Speaking of Ventilators:

Fierce Biotech

Philips piles on another trio of Class I recalls for the beleaguered ventilator portfolio

There seems to be no limit to Philips’ ventilator safety woes. Nearly a full year after initiating a recall of many of its respiratory devices that have since stretched to encompass around 5.2 million machines distributed around the world, the company continues to accumulate safety notices for those and other devices in its vast Respironics portfolio.

The latest safety event concerns the V60, V60 Plus, and V680 ventilators. Though all three models escaped the original far-reaching recall, about 1,500 of the V60 and V60 Plus machines were the target of yet another FDA notice earlier this year.

This time around, the trio of ventilators is the subject of a total recall, spanning at least 99,000 devices distributed across the U.S. and around the world. As of this week, the FDA has issued its most serious Class I rating to the safety notices for all three models.

The V60 and V60 Plus ventilators have been cleared by the FDA to provide high-flow oxygen therapy and noninvasive ventilation in healthcare facilities, while the V680 device is designed to offer both invasive and noninvasive ventilation to critically ill patients in the intensive care unit and has yet to be cleared in the U.S.

Philips piles on another trio of Class I recalls for beleaguered ventilator portfolio | Fierce Biotech

[TimaaaaaaaahRocks]

Seems that they chose the wrong adhesive. Why the adhesive fails is an interesting data point. Temperature, humidity, vibration, etc.

But that doesn't concern me as much as the why the alarms don't work with the fault occurs.

"The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death." An mtbf analysis would not look pretty.  The V60 has a lot in common with the DS1 and other toxic foam machines. The evidence clearly uncovered a shoddy design taken to market with an inadequate failure analysis. Any problem that causes the alarm to fail should be a no-go. Then ya got the whole 'expired adhesive' thing proving they don't have their material and production processes under control. Dangggg what does a #6 screw and Nyloc nut cost these days? A heck of a lot less than a class 1 recall. Dog food factories are held to higher standards than medical device manufacturers.

[ST Dog]

Dangggg what does a #6 screw and Nyloc nut cost these days? A heck of a lot less than a class 1 recall. Dog food factories are held to higher standards than medical device manufacturers.

Never seen a capacitor held to a PCB with a screw.

Only ever seen that on my AC unit, for the run/start caps to hold them in the metal panel.

Dog food factories do not have to go through anything near the qualification process medical devices do.

But just like the FAA with aircraft, it's not perfect.
Unforeseen failures, bad/unrealistic assumptions in the hazard analysis,  poor requirements, development standards not followed, etc.

Neither you nor I have seen the hazard assessment or other safety documents the FDA looked at to approve the device.

[TimaaaaaaaahRocks]

Never seen a capacitor held to a PCB with a screw.

Only ever seen that on my AC unit, for the run/start caps to hold them in the metal panel.

Dog food factories do not have to go through anything near the qualification process medical devices do.

But just like the FAA with aircraft, it's not perfect. Unforeseen failures, bad/unrealistic assumptions in the hazard analysis,  poor requirements, development standards not followed, etc.

Neither you nor I have seen the hazard assessment or other safety documents the FDA looked at to approve the device.

Never seen a capacitor held to a PCB with a screw. Only ever seen that on my AC unit, for the run/start caps to hold them in the metal panel.

I have, but the capacitor in question in the V60 is (in)secured to the chassis with mechanical bracket and the leads are soldered to the PCB. If you haven't seen one up close and personal check out the attachment. The capacitor comes loose from the mechanical bracket and the leads fail on the PCB, and bingo.

Dog food factories do not have to go through anything near the qualification process medical devices do.

Really? Yet PR was able to produce defective garbage for years. The FDA shut down Bravo Packing for making dog food, poorly. But PR blows their nose at the FDA regulations with zero consequences beyond having to replace their garbage products.  

But just like the FAA with aircraft, it's not perfect. Unforeseen failures, bad/unrealistic assumptions in the hazard analysis,  poor requirements, development standards not followed, etc.

The Boeing dash 8 fraud exposed the FAA's incompetence and lack of concern for public safety. File one set of design criteria with the FAA but ship something completely different. Tell the FAA that mcas will limit the correction to no more than 0.6 degrees one time, then change the software to 2.5 degrees an unlimited number of times. *golf-clap* Why? because the basic design of the aircraft was flawed and certainly not substantially equivalent to prior 737 designs, which the FAA accepted.  

Neither you nor I have seen the hazard assessment or other safety documents the FDA looked at to approve the device.

The FDA approved the V60 under a 510K application as Substantially Equivalent (SESE) to a prior product(s). Therefore NOBODY outside of PR saw any safety related documents if they were even done at all. A 510K is an application that says you jumped through all of the hoops, it does not include any proof that the manufacturer did ANY testing or analysis. They simply check the box that says WE DID IT [x]. 

Great regulatory agencies we have here in the USA. We have good processes but they lack competent oversight and enforcement. 

[ST Dog]

I have, but the capacitor in question in the V60 is (in)secured to the chassis with mechanical bracket and the leads are soldered to the PCB. 
...
Great regulatory agencies we have here in the USA. We have good processes but they lack competent oversight and enforcement. 

Was that design used in an earlier machine? If so it would meet the similarity argument.

It's odd, but man that's a big cap for this sort of device.

The regulators have limited manpower. Talk to congress. Either they need to increase the budget or direct the funding better.

(The MCAS changes were sent to the FAA. Boeing didn't think they were a big dial so didn't highlight them. I forget now what it was but other changes were focused on by the FAA. It also highlights another issue, who decides a change needs to be reevaluated by safety? There is no clear process for that)

[btreger]

More Class-action Lawsuits for Philips

Lawyers and Settlements

MEDICAL DEVICE SUPPLIERS HIT PHILIPS RESPIRONICS WITH CLASS ACTION

Glenside, PA. Philips is hit again with a class-action lawsuit, but this time medical device makers join thousands of consumers who filed complaints about the defective sleep apnea machines alleged to cause cancers and respiratory injuries. Baird Respiratory Therapy, Inc., filed in March 2022 a class action lawsuit against Philips in the U.S. District Court for the Eastern District of Pennsylvania, seeking to represent durable medical equipment (DME) suppliers nationwide who purchased Philips’ recalled breathing machines.


Baird claims that Philips breached its express warranty and misrepresented the potential risks (cancer and other injuries) inherent in the polyester-based polyurethane (PE-PUR) foam found in the machines. Because Philips “unreasonably delayed its recall” by waiting to notify Baird and other suppliers of reports indicating that the PE-PUR foam could breakdown and put users in harm’s way and it knowingly allowed its packaging, labels, advertisements, promotional materials, and websites to intentionally mislead Baird and other suppliers about the recalled products, Baird and other suppliers lost money when they were unable to resell the recalled CPAP and BiPAP machines.  The case is Baird Respiratory Therapy, Inc. v. Philips, 2:22-cv-00886.

Medical Device Suppliers Hit Philips Respironics with Class Action (lawyersandsettlements.com)