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

Model Number V60

Device Problems Use of Device Problem (1670); Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.02mar2021.

Event Description

It was reported to philips that the nav ring was not working properly and was unable to adjust the settings.The device was not in clinical 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.

Manufacturer Narrative

G4:16mar2021.B4:21mar2021.The philips field service engineer replaced the front bezel to resolve the issue.The device passed testing and was confirmed to meet specification fully, and was returned to use.A similar investigation was performed it was determined due to liquid ingress caused the navigation ring failures.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: 11400574
• MDR Text Key: 238875446
• Report Number: 2031642-2021-00790
• 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: 02/02/2021

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
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 03/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2014
• 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