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

Model Number V60

Device Problem Power Conditioning Problem (1474)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 22sep2020.

Event Description

The customer reported the blower stalled while in use.The device was providing therapy to a patient at the time of the event, however no patient harm was reported.

Manufacturer Narrative

G4: 13jan2021.B4: 14jan2021.The customer advised the ventilator was showing 0 for 35v supply, and the error logs showed several errors: check vent blow stalled or blower not running at required speeds.,check vent aux alarm supply failed, 35v supply failed and check vent backup alarm failed.The remote service engineer advised changing the power management board or motor controller board to see if it resolves the issue, so the customer requested onsite support.The field service engineer (fse) went onsite to service the ventilator.When the fse powered on the ventilator, it displayed multiple check vent alarms, as the customer reported, and the touchscreen locked up when attempting to power down.The ventilator would not power down until the ac power source and the backup battery was disconnected.The fse replaced the power management board and performed testing.The testing passed, and the issue was resolved.Following the repair, the device was returned to the customer to be placed back into service.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: 10568264
• MDR Text Key: 208529151
• Report Number: 2031642-2020-03404
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2011
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER