MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. DREAMSTAION BIPAP PRO / AUTO BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Date 03/20/2021

Event Type  malfunction  

Event Description

A recall was issued for my device in 2021.It's march 28th 2023.After years of interminable hours on the phone and emailing philips; speaking with a dozen different customer service agents; confirming - via phone - multiple times that they have all of the information that they need to issue a replacement device, i still have not received my replacement product.

• Brand Name: DREAMSTAION BIPAP PRO / AUTO BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 16657366
• MDR Text Key: 312519705
• Report Number: MW5116180
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/28/2023

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 Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other