MAUDE Adverse Event Report: RESPIRONICS BIPAP V60

Model Number V60

Device Problems No Display/Image (1183); Device Inoperable (1663); No Flow (2991)

Patient Problem No Code Available (3191)

Event Date 02/20/2017

Event Type  Injury  

Event Description

Bipap machine beeping, the bipap console was black, not on, not working.The pt had the mask on and all tubing was connected, but no air moving.Pt required intervention to assist with breathing.

• Brand Name: BIPAP V60
• Type of Device: BIPAP
• Manufacturer (Section D): RESPIRONICS; carlsbad CA 92011
• MDR Report Key: 6375990
• MDR Text Key: 69143518
• Report Number: MW5068238
• Device Sequence Number: 1
• Product Code: BZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 89