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

Model Number DSX500S11F

Device Problem Degraded (1153)

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

Event Date 09/08/2023

Event Type  malfunction  

Event Description

The manufacturer received a voluntary medwatch (mw5145600) regarding the field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging patient harm.The patient stated ¿i started using the phillips dream station 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 have 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.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: REP DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17886856
• MDR Text Key: 325117860
• Report Number: 2518422-2023-25846
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500S11F
• Device Catalogue Number: DSX500S11F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1