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).Date of report: 19aug2019.The customer confirmed the 35v failure.The customer reported that replacing the power management (pm) pcba corrected the reported issue and that the battery was fully charged.

Event Description

The customer reported a 35v failure.There was no patient involvement.

Manufacturer Narrative

G4: 22jul2020 b4: (b)(6) 2020 the visual inspection of the power management board printed circuit board assembly (pm pcba) no anomalies noted.A failure investigation (fi) technician installed the pm pcba a fi ventilator found the 24v shorted.The failure was identified to integrated circuits (ic) in reference designation u1 on the pm pcba damaged.Customer complaint verified.Root cause was failure of ic in reference designation u1 on the pm pcba damaged.The determination could be made that the device failed to meet specifications.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: 8907071
• MDR Text Key: 170230152
• Report Number: 2031642-2019-06533
• 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: 07/31/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 07/31/2019
• Supplement Dates FDA Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1