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

Model Number V60

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of this report: 17feb2021.

Event Description

It was reported that while the ventilator was in operation "backup alarm failed" was displayed and an alarm sounded.The ventilator was in use with a patient at the time of the alarm, and the patient was swapped to a different ventilator.No additional patient harm was reported.

Manufacturer Narrative

G4:08mar2021.B4:13mar2021.The field service engineer (fse) performed periodic maintenance.The reported issue was unable to be confirmed by an operational check performed.Since the backup alarm failed error was confirmed in the event log, the central processing unit board that had a backup alarm function was replaced by the fse to prevent a recurrence.The issue is resolved.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

The central processing unit printed circuit board assembly was returned for failure investigation.The piezo buzzer (ls1) was failing intermittently due to the insulation resistance was out of specification 457 kohms.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11339483
• MDR Text Key: 233796627
• Report Number: 2031642-2021-00629
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2018
• 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