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

Model Number V60

Device Problem Failure to Align (2522)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 09oct2020.

Event Description

It was reported to philips that during periodic maintenance there was a misalignment with the touch position on the touchscreen.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 philips service technician and the issue was confirmed.The touchscreen was replaced to resolve the reported issue and the device passed functionality testing.

Manufacturer Narrative

G4:19jan2021, and b4:25jan2021.Touch screen assembly was returned for evaluation.Visual inspection revealed no signs of damage or contamination.A failure investigation (fi) technician installed the touchscreen assembly into a fi ventilator to duplicate the reported issue.During the unit testing the touchscreen assembly was installed in the fi test ventilator and fault was found on this returned touchscreen.The resistance measurement failed and this touchscreen assembly failed to meet specification.The reported complaint was confirmed.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: 10659564
• MDR Text Key: 211913552
• Report Number: 2031642-2020-03657
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832
• 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: 09/18/2020

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: No Information
• Device Model Number: V60
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 09/18/2020
• Supplement Dates FDA Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2018
• 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