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

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problem Cancer (3262)

Event Date 04/14/2023

Event Type  Injury  

Event Description

I have been diagnosed with cancer in my liver after using the philips dream station auto bipap machine.I am currently undergoing testing to see if the cancer has spread from my liver.It was discovered during a routine gallbladder removal (b)(6) 2023.The original machine that i used was returned in the recall and after months they sent me a "reconditioned" one.

• Brand Name: PHILIPS DREAM STATION AUTO BIPAP
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS/ RESPIRONICS INC.
• MDR Report Key: 16887807
• MDR Text Key: 314866667
• Report Number: MW5117348
• 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: Patient
• Type of Report: Initial
• Report Date: 05/03/2023

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: 05/05/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White