MAUDE Adverse Event Report: PHILIPS / RESPIRONICS INC. PHILIPS DREAMSTATION CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Nonstandard Device (1420); Protective Measures Problem (3015)

Patient Problems Cancer (3262); Lymphoma (3263)

Event Date 07/15/2021

Event Type  Injury  

Event Description

I have a dreamstation philips cpap, recalled in june 2021, replaced in october 2021.Your site says: https://www.Fda.Gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due#repairedreplaced repaired and replaced bipap or cpap machines recommendations for people who use bipap or cpap machines replaced by philips and their caregivers be aware that during the manufacturing facility inspection, the fda obtained additional information, not previously available to the fda, regarding the silicone-based foam used in a similar device marketed outside the u.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (vocs).Similar testing provided by philips to the fda on devices authorized for marketing in the u.S.Had demonstrated acceptable results.The fda has requested that philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam.At this time, the fda does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the u.S.Question: what is the status of the "additional testing"? i came down with lymphoma (blood cancer) in (b)(6) 2021, followed by kidney cancer in (b)(6) 2022.I do not trust the philips replacement and have been using my older cpap.Reference report mw5116203.

• Brand Name: PHILIPS DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 16663277
• MDR Text Key: 312725134
• Report Number: MW5116202
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White