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

Model Number V60

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 13aug2020.

Event Description

The customer reported a ventilator with a 35v supply failed alarm.There was no patient involvement or harm.

Manufacturer Narrative

G4: 05aug2020 b4: (b)(6) 2020.The service engineer (se) inspected the device and could not duplicate the reported issue.The se found in the ventilator diagnostic report error codes indicating machine and proximal pressure sensors failed, 35 volt failure , over voltage protection circuit failed, 5 volt supply failed, proximal pressure sensor autozero failed.The se was running the device for 30 minutes and device shut down with code data acquisition board (da) analog to digital converter reference failed.The se replaced power management board, motor controller board and solenoid valve.The unit was checked overall, run in tested, cleaned, functionally tested and no abnormality was confirmed.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: 10405681
• MDR Text Key: 203518074
• Report Number: 2031642-2020-02777
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• 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
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1