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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/30/2020

Event Type  malfunction  

Event Description

Bipap malfunction, rt and rn unaware of how to correct error.Retrieved a new bipap for patient.Patient desaturated to 30% minimal temporary harm.Fda safety report id # (b)(4).

• Brand Name: PHILIPS BIPAP
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC
• MDR Report Key: 11228982
• MDR Text Key: 228900488
• Report Number: MW5098990
• Device Sequence Number: 1
• Product Code: MNT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1