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

Model Number V60

Device Problem Unexpected Shutdown (4019)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 29sep2020.

Event Description

The customer called technical support (ts) reporting that the device shutdown during patient use.The device was in clinical use at the time the reported issue was discovered.No patient harm was reported.The customer evaluated the unit and confirmed the battery needed charging.The customer states the unit did alarm low battery prior to shut down.The customer restored the power connection by pushing the power cord back together completely.The customer charged the unit's battery for 24 hours and then tested the unit.The unit passed and was returned to service.

Manufacturer Narrative

G4:28sep2020.B4:02apr2021.There was a patient on the unit when the issue was discovered and the ventilator was exchanged for another one.There was no reported delay in therapy, no medical intervention, no harm to the patient or user.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: 10603932
• MDR Text Key: 209425717
• Report Number: 2031642-2020-03517
• 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: 09/02/2020

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: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2013
• 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