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

Model Number V60

Device Problem Energy Output Problem (1431)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 11sep2020.

Event Description

It was reported that the ventilator had a voltage supply failure.There was no patient involvement.The customer troubleshot with technical support and found error codes indicating a 3.3 volt failure, 5 volt supply failed and 35 volt failure.

Manufacturer Narrative

G4: 07oct2020; b4: 13oct2020.The service engineer (se) inspected the device.The se found the device was not showing voltage.The se reported that there was no issue with the power management board and replaced the motor controller board and power supply per the customer request to ensure no further issues.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: 07jan2021.B4: 08jan2021.Review of the ventilator diagnostic report found error codes indicating over voltage protection (ovp) circuit failed, motor controller printed circuit board assembly analog to digital converter (adc) failed, blower temperature high and blower temperature too high.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

G4:30dec2020 b4: (b)(6) 2021 a power supply 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 the root cause was due to the power supply component not having output.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: 10523420
• MDR Text Key: 207715747
• Report Number: 2031642-2020-03233
• 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,Followup,Followup
• Report Date: 08/21/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 08/21/2020; 08/21/2020; 08/21/2020
• Supplement Dates FDA Received: 10/13/2020; 01/06/2021; 01/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2016
• 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