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

Catalog Number DSX500S11F

Patient Problems Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 09/08/2023

Event Type  Injury  

Event Description

I started using the phillips dreamstation cpap back on (b)(6) 2019.I have been on and off cpap use for moderate to severe osa, dating back to (b)(6) 2006.I never had any issues with the older cpap machine that i had initially been prescribed for use with until i started noticing more skin irritation, redness and rash-like areas over the nasal bridge of my face, which has been a bit more prominent over the last several months.I honestly didn't know what to make of the recall back then, but started becoming a bit more concerned over some of the product parts involved, including the silicone nasal pillows breaking down and ripping, often requiring constant replacement.I even noticed holes and noticed that some of the actual tubing material itself started to break down and corrode.I had been using humidified, warm air a while, so i naturally thought the temperature within the tubing could have been partially attributing to the breakdown.So, then i decided to stop using the water and air humidification apparatus altogether and continued to see breakdowns in the tubing material itself.As a cpap user, i've always used very simple cleaning approaches, luke-warm water, gentle rinse and irrigation.So, i've been a bit concerned just with some of the actual materials that are being used for this medical grade device and though i can't be sure exactly what or how this might affect me overall in the long-term of things, my facial skin is almost developing into a burn-like rash which is quite concerning.Either way, though, i followed through with the recall process by registering my original device / cpap machine and started using the replacement device, for which i still noticed similar issues with the tubing and mask material degrading over time.Though i was never specifically instructed on returning the old device, i still have the original device on hand, along with a number of product part replacements that i have accumulated over time.Refer to additional documents in i2k.Reference report mw5145601.

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION AUTO CPAP DOM
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 17744295
• MDR Text Key: 323681251
• Report Number: MW5145600
• 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: 09/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: DSX500S11F
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: 20MG LEXAPRO TABS.; ADDERALL 10MG IR TABS.; SUNOSI 150MG TABS.
• Patient Outcome(s): Disability
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian