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

Model Number V60

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 20jan2021.

Event Description

It was reported to philips that the device had a touchscreen malfunction.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

It was reported to philips that the device's lower part of the touchscreen did not respond.The button finally responded after pressing several times.The ventilator was being used on a patient at the time of the reported event; however, there was no patient harm reported, as the ventilator reportedly kept operating.A philips service engineer (se) was dispatched to the customer site.The reported issue was confirmed and traced to a faulty touchscreen.The fse replaced the touchscreen.The device passed all performance verification testing.A failure investigation (fi) technician installed the touch screen assembly into a fi ventilator to duplicate the reported issue.The touch screen assembly was installed in the fi test ventilator and the ul_lr and ur_ll resistance were found to be out of specification.The fault was found on this returned touchscreen and the customer complaint was confirmed.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11205985
• MDR Text Key: 229867000
• Report Number: 2031642-2021-00257
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2018
• 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