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

Model Number V60

Device Problems Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 12/30/2019.

Event Description

The customer reported that the power supply was replaced but not working nor charging.There was no patient involvement.

Manufacturer Narrative

G4: 22jan2020.B4: (b)(6) 2020.The customer confirmed the reported power supply issue.The customer declined repair so the ventilator was returned unrepaired.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.

Manufacturer Narrative

G4: 25feb2020.B4: 02mar2020.H11: philips service technician evaluated the ventilator and could not confirm the reported problem of battery not charging after the power supply replacement.The service technician utilized a test battery and confirmed that it was charging when connected to alternate current (ac) power and the battery light was working within specifications.H10: the customer advised that they would be repairing the unit themselves but did not respond to multiple requests to obtain the details of the repair.No additional repair information could be obtained.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: 9533586
• MDR Text Key: 181202058
• Report Number: 2031642-2019-11013
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)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: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2019

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
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 12/12/2019; 12/12/2019
• Supplement Dates FDA Received: 01/23/2020; 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1