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

Model Number V60

Device Problems Poor Quality Image (1408); Failure to Power Up (1476); Failure to Shut Off (2939)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 29apr2020.

Event Description

It was reported that the ventilator had a dim display and will not shut off or go into standby.There was no patient involvement.The service engineer (se) inspected the device and confirmed the reported issue.The se removed the battery and tried to turn the unit on alternating current (ac) power but the unit would not turn on.The se replaced the power management (pm) board to address the reported issue and the unit was checked overall, run in tested, cleaned, functionally tested and no abnormality was confirmed.

Manufacturer Narrative

B4: 05may2020 g4: (b)(6)2020.The ventilator diagnostic report was provided and reviewed, error codes were found that indicated high tidal volume, low inspiratory pressure, low tidal volume, low minute ventilation, high rate and oxygen not available.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 10012269
• MDR Text Key: 189595359
• Report Number: 2031642-2020-01598
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

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: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 04/29/2020
• Supplement Dates Manufacturer Received: 04/13/2020
• Supplement Dates FDA Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1