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

Model Number V60

Device Problem Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 30sep2020.

Event Description

The customer reported that the unit will not power on, but they can hear a fan running and cannot get the system to power up.The customer contacted product support who advised the customer that the power management (pm) board may be faulty.The customer stated that she will give the unit to the biomed.The customer advised they will need no further assistance.Product support advised the customer that the case will remain open until next friday at which point it will be closed if we have not heard from anyone.The customer reported that the unit was not in use on a patient.

Manufacturer Narrative

G4: 06jan2021.B4: 07jan2021.Attempts were made to obtain further information regarding the device repair information and contextual information.To date, no further details have been received.The service history record was reviewed, and no repair information was found.The product support advised the customer that power management (pm) board may be faulty.The customer advised they will need no further assistance.The case is closed out.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: 10607378
• MDR Text Key: 209831559
• Report Number: 2031642-2020-03522
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• 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: 09/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2012
• 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