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

Model Number V60

Device Problems Electrical /Electronic Property Problem (1198); Battery Problem (2885); Power Problem (3010)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 01/25/2019.A follow-up report will be submitted once the investigation is completed.

Event Description

It was reported that the unit had multiple battery failures with the battery measuring 8.4 volts of direct current (dc).There was no patient involvement.The event date was not specified; estimate used.

Manufacturer Narrative

Date of report: 30jan2019.Date rec¿d by mfr: 22jan2019.The manufacturers field service engineer (fse) performed troubleshooting and confirmed the reported issue.The battery was replaced twice within the last three months along with the power management board.The fse evaluated the device logs and found an error 1124 (battery failure).The fse replaced the internal battery and harness to address the findings.The unit was ran overnight and passed all testing.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: 8279145
• MDR Text Key: 134336871
• Report Number: 2031642-2019-00544
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• 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: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1