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

Model Number V60

Device Problems Failure to Charge (1085); Unintended Power Up (1162)

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

Event Type  malfunction  

Manufacturer Narrative

Date of events: (b)(6) 2020, date of report: (b)(6) 2020.

Event Description

The customer reported that the unit is turning on by itself and the battery is not charging.The customer contacted product support and requested for part id for user interface (ui) assembly and power management (pm) board.Product support provided the part id.The customer reported that the unit was not in use on a patient.

Manufacturer Narrative

G4:11jan2021.B4:12jan2021.The biomedical engineer replaced the power management (pm) and motor controller (mc) board to address the reported issue.No other fault was noted at time of service.The battery was replaced on jan 07, 2020.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: 10603580
• MDR Text Key: 209366094
• Report Number: 2031642-2020-03508
• 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: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• 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: 09/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2012
• 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