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

Model Number V60

Device Problem Loss of Power (1475)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported a ventilator that was in use on a patient, when it shut down from being unplugged.The device was swapped for another ventilator.This event occurred during preparation for use.The customer reported that no delay of any therapy occurred, and no specific patient could be associated with this event.

Manufacturer Narrative

G4:23oct2020.B4:30dec2020.H11: b5: the customer reported that the unit was being prepared for use when the issue occurred.The unit was unplugged from ac power and the unit shuts down and battery failure alarm was identified.During troubleshooting the biomed reported a battery failed error was found in the significant log.The biomed replaced the power supply and the power management board and the problem remains.The biomed contacted product support and confirmed that the battery is the fault.The biomed replaced the battery and conducted a preventive maintenance (pm).The battery now charges and machine passed all the (pm) tests.The unit is back in 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: 10569935
• MDR Text Key: 208724701
• Report Number: 2031642-2020-03413
• 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: 09/04/2020

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: 09/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2019
• 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