Game Over! - Philips Recall & FDA Update #foamgate

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CPAP Reviews
Published at : 16 Nov 2021
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This could well be the end of Philips Respironics - Good Riddance!

As the report shows. For years they have known about the significant biological risks and they did nothing! They had the complaints, they did the tests, they had the reports they talked about it in meetings and they did nothing knowing all to well that you guys were in very real danger. That is pure evil!

We need to move on. The time is now.

Thanks for your support & look out for one another.
Your mate always.
Uncle Nicko

Links to the documents
1. FDA News Release - https://cpap.review/fda-news-release
2. FDA 483-Form Site Inspection - https://cpap.review/fda-483
3. Mishandling Of Adverse Events https://cpap.review/adverse-events

00:00 - FDA Conducts Philips Site Inspection
01:00 - FDA CPAP Recall Approval & Silicone Foam
02:10 - FDA Requests Independent Lab Results
02:50 - The FDA Inspector Report - 483
04:20 - Site Report - Observation 1.A
05:49 - Observation 1.B - Trilogy Maintenance Procedure
06:50 - Observation 1.C - Risk Analysis
09:55 - Observation 1.D - A Series CPAP - Silicone Foam
11:15 - Observation 2 - 220,000 Complaints!
12:35 - Observation 3 - Ventilators Health Hazard Report 2018
13:03 - Observation 4 - Design Change Procedures - Trilogy Ventilators
13:50 - Observation 5 - Change Not Reported To FDA
14:15 - Observation 6 - Shit Management & Executive Team
15:20 - Observation 7 - Foam Supplier Procedures
15:50 - Observation 8 - No Supplier Qualification Forms
16:40 - Mishandling Of Adverse Events
19:28 - Conclusion - Game Over!

#philips #cpap #recall

Philips RecallFDA Site InspectionFDA recall update

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