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

Model Number V60

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 16sep2020.

Event Description

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

G4:21dec2020 b4:(b)(6)2020 a touchscreen assembly was returned for analysis.The visual inspection of the touchscreen assembly revealed no evidence of damage or contamination.A failure investigation (fi) technician installed the touchscreen a fi ventilator to verify and test the functionality.The returned touchscreen assembly was found to have the resistance measurements out of specification.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

G4: 18sep2020.B4: 22sep2020.The customer requested that a philips field service engineer (fse) be dispatched to the customer site.The reported issue was confirmed and traced to a faulty touchscreen.The fse replaced the touchscreen.Device passed all performance verification testing.Following the repair, the device was returned to the customer to be placed back into 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: 10542293
• MDR Text Key: 208107718
• Report Number: 2031642-2020-03306
• 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: 08/26/2020

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: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 08/26/2020; 08/26/2020
• Supplement Dates FDA Received: 09/23/2020; 12/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2017
• 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