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

Model Number	V60
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 18sep2020.
Event or Problem Description
It was reported to philips that the device had a power supply failure.The device was not being used on a patient at the time of the event.There was no patient or user harm reported.
Additional Manufacturer Narrative
The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The customer discovered numerous errors in the event log.The customer indicated there were other technicians working on the device and wanted to confirm if the errors in the event log were resolved.After speaking with senior technician the power management printed circuit board assembly (pm pcba) was replaced to resolve the reported issue.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.
Additional Manufacturer Narrative
G4:01apr2021.B4:05apr2021.The removed power management printed circuit board assembly (pm pcba) was returned to the failure investigation lab (fi).A visual inspection of the pm pcba revealed no evidence of damage or contamination.The fi technician installed the pm pcba into a fi ventilator to duplicate the reported issue and no failures were identified.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
• Common Device Name: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 10557214
• Report Number: 2031642-2020-03339
• Device Sequence Number: 3208970
• Product Code: MNT
• UDI-Device Identifier: 00884838025738
• UDI-Public: (01)00884838025738
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K082660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2020

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
• Operator of Device: Health Professional
• Device Model Number: V60
• Device Catalogue Number: U1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 08/28/2020; 08/28/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 12/01/2020; 04/05/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1