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

Device Problems Nonstandard Device (1420); Defective Component (2292)

Patient Problem Cancer (3262)

Event Type  malfunction  

Event Description

Philips auto sv bipap and cpap recalled - possible release of carcinogenic gases due to defect in noise reducing foam.Affected cpap used 12/2018 to 6/2019.Affected bipap purchased (b)(6) 2019 to replace cpap due to more extensive sleep apnea.Squamous cell carcinoma (base of tongue) diagnosed (b)(6) 2020.Fda safety report id# (b)(4).

• Brand Name: RESPIRONICS BIPAP AUTO SV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12161009
• MDR Text Key: 261679479
• Report Number: MW5102506
• Device Sequence Number: 1
• Product Code: MNS
• 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: 07/09/2021
• 2 Devices were Involved in the Event: 1 2

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: 07/12/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1