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

Model Number V60 PLUS

Device Problems Loss of Power (1475); Battery Problem (2885)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.08mar2021.

Event Description

The customer called into technical support (ts) reporting that the device¿s battery failed alarm and turns off even on ac.This event was reported to have occurred during clinical use.There was no allegation of harm associated with this event.The device was being set up when the issue occurred and that unit never came in contact with the patient.The customer used another v60.The manufacturer¿s international service technician evaluated the ventilator and confirmed the reported problem.The data acquisition rp-pcba failed after switching on the equipment.The service technician replaced the data acquisition board assembly (da pcba) and the problem was resolved.The device was put back into service.

Manufacturer Narrative

G4:29mar2021.B4:06apr2021.H11: b5: the customer called technical support (ts), reporting that the device displayed a machine pressure sensor auto zero failed and speaker test (pm pcba & mc pcba) error message.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

G4:29mar2021.B4:09apr2021.The technical support found no problem with the speaker test.The equipment passed testing.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 data acquisition assembly (daq) was received for failure investigation.Visual inspection of the daq revealed no evidence of damage or contamination.The daq was tested and root cause is failure of daq assembly, caused by u7 drifting out of calibration.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11440956
• MDR Text Key: 240055856
• Report Number: 2031642-2021-00883
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/02/2021

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: Health Professional
• Device Model Number: V60 PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: 02/08/2021; 02/08/2021; 08/03/2021
• Supplement Dates FDA Received: 04/06/2021; 04/09/2021; 09/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2020
• 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