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

Model Number V60

Device Problems Loss of Power (1475); Self-Activation or Keying (1557)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 24sep2020.

Event Description

It was reported that the ventilator while the device was being checked in the medical engineer room it started up on its own.Reportedly, the medical engineer (me) then stopped the device and then it restarted again repeatedly.There was no patient involvement.The manufacturer¿s international service technician inspected the device and when it was started up it shutdown immediately after it went to the service menu.The power button responded poorly and it needs to be pressed repeatedly in order to start up the device.In addition the patient disconnect alarm sounded.

Manufacturer Narrative

G4: 25sep2020.B4: 29sep2020.The manufacturer¿s international service technician reported that the reported issue was caused by the user interface (ui) board.The ui board will be replaced once the customer approves the quote for repair/service of the device.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: 26oct2020.B4: 27oct2020.Information was received that the reported issue was confirmed and the user interface assembly was replaced to address the reported issue.The unit was checked overall, run in tested, cleaned, functionally tested and no abnormality 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.

Manufacturer Narrative

G4:15jan2021.B4:19jan2021.A user interface assembly was returned for analysis.A visual inspection of the returned component was performed, no notable conditions were found.An investigation was performed and the product analysis technician reported that no fault was found.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: 10581202
• MDR Text Key: 208795907
• Report Number: 2031642-2020-03437
• 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: foreign,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2012
• 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