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

Model Number DSX700T11

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/17/2023

Event Type  malfunction  

Event Description

My philips, respironics inc bipap device was recalled in 2021.Philips notified me 5 months ago that my replacement was ready to be shipped.The replacement is never shipped.I have repeatedly called philips and consistently am told that the replacement is in shipping and i would be contacted.This never happens.I am without a replacement device with no recourse.

• Brand Name: AUTO BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 16515613
• MDR Text Key: 311128536
• Report Number: MW5115627
• 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: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700T11
• Device Catalogue Number: DSX700T11
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BIPAP ; D3; ROSUVASTATIN
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White