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

Model Number V60

Device Problems Failure to Charge (1085); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 08oct2020.

Event Description

It was reported to philips that the battery was not charging and alarming when powered on.The device was not in clinical use at the time of the event.There was no report of patient or user harm.The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The customer reported errors in the significant event logs.The rse advised the caller to swap out the pm pcba or mc pcba to help diagnose the problem.

Manufacturer Narrative

G4: 19oct2020 b4: (b)(6) 2020 b5 updated: it was reported to philips that the battery was not charging and alarming when powered on.The device was not in clinical use at the time of the event.There was no report of patient or user harm.The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The customer reported blower stalled, auxiliary alarm supply failed, 35 v supply failed, backup alarm failed and alarm led failed errors in the significant event log, the rse advised the caller to swap out the pm pcba or mc pcba to help diagnose the problem h10: multiple good faith efforts were made to obtain information regarding device evaluation, repair, and operational status with no response from the reporter and therefore cannot be determined.If additional information is later obtained, a supplemental report will be submitted.1.Tuesday, (b)(6) , 2020 11:12 am emailed (b)(6) ; 2.Thursday, (b)(6) , 2020 8:42 am emailed (b)(6) ; 3.Monday, (b)(6) , 2020 11:42 am emailed (b)(6) 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.

Manufacturer Narrative

The power management board was returned to the failure investigation lab for analysis.There were no visual anomalies noted.Testing of the part confirmed the customer's reported issue.The root cause was determined to be a failure of transistor q11.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 10653204
• MDR Text Key: 211649037
• Report Number: 2031642-2020-03646
• 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,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2016
• 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