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

Model Number DREAMSTATION ASV

Device Problems Nonstandard Device (1420); Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/01/2021

Event Type  Injury  

Event Description

My phillips respironics dreamstation asv bipap respirator (b)(4) has been under recall since 06/01/2021.One year ago, i was told that my respirator would be replaced no later than 01/01/2023.My supplier (medicor) is not able to give me a date for the replacement of my respirator.My respirator does not function properly and my last 2 sleep studies indicate that my sleep apnea has increased to a critical level and my respirator is not able to serve its purpose.In fact, the automatic start function does not work most of the time, which leads me to wonder if other functions of my respirator are not working properly.This may be the reason that my sleep apnea has worsened.I have tried to call phillips and all i get is a recording.I need to speak to someone so that i can get a replacement respirator.

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION ASV
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 16618345
• MDR Text Key: 312139511
• Report Number: MW5115976
• 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: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: DREAMSTATION ASV
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Hispanic
• Patient Race: White