MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX900H11C

Device Problems Nonstandard Device (1420); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

I have a philips respironics dreamstation bipap autosv that was recalled.Sn (b)(4), (b)(6) 2022, i did the online recall forums philips provided to get recalled device serviced or replaced.Https://www.Philipssrcupdate.Expertinquiry.Com/ conformation number (b)(4).This is a device i use nightly due to severe central sleep apnea.I have received 3 generic emails from philips that have been useless.Calling philips they want me to check a website and wait for dme(durable medical equipment) provider.Going through the pt portal website thing they wanted me to check it also tells me to wait for a call from my dme provider.Talking to my dme provider they have no idea and said i need to talk to philips.I am lost and have no idea what to do.I don't think my device has been exposed to too much ozone, but i have worked ems for 8 years and my bipap was in the truck as it was being decontaminated by ozone generators, as well as other devices especially during the height of covid until i found out that could be an issue.Thank you for your time and hopefully you guys might be able to help.

• Brand Name: BIPAP AUTOSV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 16529387
• MDR Text Key: 311229532
• Report Number: MW5115666
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/08/2023

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 Model Number: DSX900H11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2023
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White