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

Model Number V60

Device Problem Energy Output Problem (1431)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 23sep2020.

Event Description

It was reported to philips that the device had an over voltage protection issue.The device was not being used on a patient at the time of the event.There was no patient or user harm reported.

Manufacturer Narrative

G4: 06nov2020 b4: (b)(6) 2020 an authorized service personnel(asp) was dispatched to the customer site and it was determined that the power management printed circuit board assembly (pm pcba) needed to be replaced to return the device to working condition.The asp replaced the pm pcba.The device passed performance verification testing.Following the repair, the device was returned to the customer to be placed back into service.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: 10577929
• MDR Text Key: 208724281
• Report Number: 2031642-2020-03433
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 884838025776
• UDI-Public: (01)884838025776
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/05/2020

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: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 09/05/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1