MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. BIPAP V60; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Connection Problem (2900)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/11/2022

Event Type  Injury  

Event Description

O2 line was connected to flowmeter by rcp taking care of pt.Upon my arrival, pt desat85-89% and placed on 100%.Bipap displayed no oxygen available.Bipap trouble shooted and was found to not be properly connected to 50psi outlet.

• Brand Name: BIPAP V60
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 16364513
• MDR Text Key: 309514881
• Report Number: MW5114892
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian