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

Model Number V60

Device Problem Failure to Shut Off (2939)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 01oct2020.

Event Description

It was reported to philips that the device was unable to shut down.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

G4:30dec2020.B4: 04jan2021.A philips field service engineer (fse) was dispatched to the customer site.The fse confirmed the reported allegation, and observed multiple check vent alarms.The fse replaced the central processing unit printed circuit board assembly (cpu pcba),power management printed circuit board assembly (pm pcba), motor control printed circuit board assembly (mc pcba) to resolve the issue and bring the device back to functionality.The removed cpu pcba, pm pcba, mc pcba were returned for analysis.A failure investigation (fi) technician installed the cpu pcba, pm pcba, mc pcba into a fi ventilator to verify and test the functionality.The reported issue was verified.The cpu pcba, pm pcba were found to have no faults and the root cause of the issue was revealed to be crack of the mc pcba c202 capacitor.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: 10617630
• MDR Text Key: 209782428
• Report Number: 2031642-2020-03546
• Device Sequence Number: 1
• Product Code: MNT
• 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: 09/14/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 09/14/2020
• Supplement Dates FDA Received: 01/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2012
• 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