MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2020

Event Type  malfunction  

Event Description

Malfunctioning bipap: respiratory therapist (rt) placed bilevel positive airway pressure (bipap) on the patient.At first, it was working as usual and nothing unusual was noticed.While titrating fraction of inspired oxygen (fio2) on the bipap, it turned off while running on the patient for about a second.Bipap turned back on by itself.Rt checked all the connections, and everything was plugged in how it is supposed to be.Then there was a flashing light on the bipap as it would be running on internal battery.After switching to a different outlet, the light stopped flushing, however, bipap would alarm as a low priority alarm (also same way as it would be alarming when it is running on the battery).Bipap was exchanged, pulled and yellow tagged.Manufacturer was notified for their investigation, found that the main board (cpu pcba) had failed.The board was replaced and passed testing, returned to service.Manufacturer response for bipap v60, respironics (per site reporter): manufacturer completed repair on the device.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos ct; carlsbad CA 92011
• MDR Report Key: 11841103
• MDR Text Key: 251131682
• Report Number: 11841103
• 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
• Type of Report: Initial
• Report Date: 05/05/2021

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
• Device Operator: Other
• Device Model Number: V60
• Device Catalogue Number: U1053617
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2021
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA
• Patient Weight: 73