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

Model Number V60

Device Problems No Display/Image (1183); No Device Output (1435); Failure to Shut Off (2939)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 04jan2021.

Event Description

The customer reported that the unit attempted to be turned on during pre-use check but the screen remained black.The power led illuminated but no airflow was delivered.The unit failed to cut off the power.The customer contacted product support and reported that they contacted a dealer staff member then the dealer member confirmed the phenomenon on site.The screen display remained black and the power led illuminated but no airflow was delivered.The customer reported that the unit was not in use on a patient.The issue was discovered during pre-use check.No delay in therapy and no medical intervention reported.The issue was associated with the power management (pm) board recall.The (pm) board will be handled following the instruction in the recall.

Manufacturer Narrative

G4:21apr2021; b4:26apr2021.The service technician reported that the reported phenomenon was confirmed through operation checking.By doing parts-replacement investigation, it was identified that the phenomenon was resolved by replacing the power management (pm) board.The power management board was replaced under voluntary recall.The service technician reported when battery performance testing was carried out, the power was observed to turn off in the middle due to battery deterioration.The output of the battery was measured, and the result was that it was 0 v.In addition, the event log revealed that diagnosis code (internal battery failed) had occurred.Although there was no reproducibility despite operation checking, the lithium-ion battery was replaced due to deterioration and as preventative maintenance against recurrence.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: 11113764
• MDR Text Key: 226057252
• Report Number: 2031642-2021-00014
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1622-2020
• Patient Sequence Number: 1