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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 28may2020.

Event Description

It was reported when the unit was powered on an alarm sounded for over voltage protection.There was no patient involvement.

Manufacturer Narrative

G4: 18jun2020.B4: 18jun2020.The international service technician evaluated the unit and the over voltage protection alarm was confirmed in the significant event log though it was not able to be duplicated.The technician replaced the motor controller board and resolved the problem.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

G4:23nov2020, b4:11dec2020.The motor controller (mc) pcba was received for internal failure analysis.The mc pcba was tested and no failures were identified.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: 10099197
• MDR Text Key: 193400263
• Report Number: 2031642-2020-01893
• 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
• Report Date: 05/11/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 05/11/2020; 05/11/2020
• Supplement Dates FDA Received: 06/18/2020; 12/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2016
• 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