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

Model Number V60

Device Problems Self-Activation or Keying (1557); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 28sep2020.

Event Description

The customer reported that the unit turns and off by itself and the power button does not work.Also customer reports that they were getting a battery failed error.The customer reported that the unit was in use on patient , but there was no patient harm reported.The customer contacted product support and reported that replacing the battery corrected the battery failure error.Product support suggested that the customer swap graphic user interface (gui) to determine if the issue is in the gui or not.Discussed 1st and 2nd generation liquid crystal display (lcd).Advised customer to replace the user interface board.

Manufacturer Narrative

G4:30nov2020.B4:17dec2020.Per customer replacing the user interface board and battery corrected the reported problem.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.

Manufacturer Narrative

G4:15feb2021.B4:07mar2021.H11:g5:k102985.H11: per bio-med, the issue was discovered when the unit was turned on, and few minutes the unit was alarmed with battery failure.The biomed said that the unit was not in use on a patient, and no delay in therapy was reported.The bio-med stated that the unit turning on and off by itself and the unit could not be turned off was corrected after the battery was replaced and charge.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: 10597144
• MDR Text Key: 209774836
• Report Number: 2031642-2020-03467
• 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,Followup
• Report Date: 09/09/2020

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: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 09/09/2020; 02/15/2021
• Supplement Dates FDA Received: 12/17/2020; 03/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2013
• 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