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

Model Number V60

Device Problems Defective Alarm (1014); Failure to Power Up (1476); Problem with Software Installation (3013); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.(b)(6)2021.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.

Event Description

It was reported to philips that when installing the 3.0 software on the device, the computer froze at 90% and now the vent does not power on, and alarms.The device was not in use at the time of the event.There was no report of patient or user harm.

Manufacturer Narrative

G4: 19jan2021.B4: 20jan2021.The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The rse advised the customer to try to unplug battery and ac, wait a few minutes and try installing the software.The rse also advised to try to reload software as long as the unit is powered on, and if it does not work, suspect that the cpu pcba needs replacement.The part information for a replacement cpu pcba was provided to the customer.Multiple good faith efforts were made to obtain information regarding device evaluation, repair, and operational status with no response from the reporter and therefore cannot be determined.If additional information is later obtained, a supplemental report will be submitted.1.Tuesday, december 22, 2020 9:24 am emailed (b)(6).2.Monday, january 4, 2021 11:10 am emailed (b)(6).3.Wednesday, january 13, 2021 2:22 pm emailed (b)(6).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: 11136664
• MDR Text Key: 226846938
• Report Number: 2031642-2021-00074
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• 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: 12/11/2020

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: 1053617
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2018
• 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