MAUDE Adverse Event Report: 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: 06oct2020.

Event Description

It was reported to philips that the device only operates on battery power.The device was not in clinical use at the time of the event.A good faith effort was made and the biomed stated that this v60 was in storage and the technician took it out to ensure it was operating correctly before placing into service, and that is when it was noted that it was only working on battery power.This device was never placed on a patient and another v60 was placed into service to fill the need.There was no delay to patient therapy and no report of patient or user harm.This issue was noted during pre-use check.The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The customer stated that with the unit off and the ac and battery connected there is no power led illuminated on the front of the device.The customer stated when powered on, it only powers on with the battery power.A philips field service engineer (fse) has been dispatched to the customer site to provide additional assistance.

Manufacturer Narrative

G4:14dec2020.B4:15dec2020.The field service engineer replaced the power supply to resolve the issue.The device passed all performance assurance testing and was returned to 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
• MDR Report Key: 10636458
• MDR Text Key: 214800401
• Report Number: 2031642-2020-03587
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

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: 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: 09/15/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1