MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC. PHILIPS RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/03/2022

Event Type  malfunction  

Event Description

Patient was on 6 l nasal cannula, when patient alarm showed desaturation.Staff attempted to apply bipap v60 machine, however, screen was frozen.Unable to get screen functioning.Patient continued to decompensate and was intubated.

• Brand Name: PHILIPS RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC.; 6501 living place; pittsburgh PA 15206
• MDR Report Key: 14205769
• MDR Text Key: 290054941
• Report Number: 14205769
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/15/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2022
• Date Report to Manufacturer: 04/26/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA