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

Model Number V60

Device Problem Self-Activation or Keying (1557)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 05feb2021.

Event Description

It was reported to philips that the device's touchscreen is selecting functions and changing parameters automatically, without the user touching the screen.The device was not reported to be in clinical use at the time of the event.This issue was found during testing of the device.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 and confirmed the touchscreen interface required replacement.A replacement parts has been ordered to be installed by the fse.

Manufacturer Narrative

G4:18feb2021.B4:06mar2021.H11:g5:k102985.H10: philips field service engineer (fse) was dispatched to the customer site to provide additional assistance and confirmed the touchscreen interface required replacement.A replacement part was been ordered to be installed by the fse.The fse replaced the touchscreen to resolve the reported issue.The device successfully passed all testing performed after repair and returned to full functionality.The device 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.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11289780
• MDR Text Key: 240618204
• Report Number: 2031642-2021-00457
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

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: 01/08/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 03/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2015
• 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