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: 11dec2020.
Event or Problem Description
It was reported to philips that the device shutdown and restarted while in use and the unit was alarming low priority alarm even though the settings were not changed.The device was in use at the time of the event.There was no report of patient or user harm.A philips field service engineer (fse) was dispatched to the customer site to provide additional assistance.
Additional Manufacturer Narrative
G4:05jan2021; b4:12jan2021.The device was in use at the time of the event.The patient was swapped to another v60 to continue treatment and there was no report of patient or user harm.Philips field service engineer (fse) was dispatched to the customer site to provide additional assistance.The fse found an error code consistent with ventilator restarted due to anomalies detected during operation in the event log and confirmed that the central processing unit (cpu) printed circuit board assembly (pcba) required replacement.The fse replaced the cpu pcba and ran a full performance verification test (pvt).The device passed all testing successfully 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.
Additional Manufacturer Narrative
The central processing unit (cpu) was returned to the manufacturer for failure evaluation.Failure investigation could not duplicate the reported issue on the returned cpu pcba, and the event log had been cleared; additionally, no other failures were identified in their investigation.The alleged complaint of device restarting could not be confirmed.

• Brand Name: V60 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 10995800
• Report Number: 2031642-2020-04512
• Device Sequence Number: 17129763
• Product Code: MNT
• UDI-Device Identifier: 00884838025738
• UDI-Public: (01)00884838025738
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K102985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2021

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: No Information
• Device Model Number: V60
• Device Catalogue Number: U1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 11/16/2020; 07/09/2021
• Initial Report FDA Received Date: 12/12/2020
• Supplement Report FDA Received Date: 01/13/2021; 08/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER.