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

Model Number V60

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Reported: 24feb2021.

Event Description

The customer reported when the unit was operating, there was an issue with it not running correctly.The customer confirmed the touch panel was inoperable.The field service engineer (fse) also identified diagnostic error, "system restart," but it could not be replicated.The fse replaced the touchscreen to resolve the issue.The unit was tested and it was returned to service.The unit was not in use, and there was no patient or user harm reported.

Manufacturer Narrative

The field service engineer replaced the central processing unit (cpu) as a preventive measure.The touchscreen was returned to the manufacturer for failure analysis.The reported complaint of touchscreen failure is not duplicated.There is no fault found on this returned touchscreen assembly.The cpu board was also returned for failure analysis, and no failures were identified.The system restart error could not be duplicated.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11375944
• MDR Text Key: 234609025
• Report Number: 2031642-2021-00726
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• 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: 08/12/2021

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
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 05/12/2021
• Supplement Dates FDA Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2017
• 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