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

Model Number V60

Device Problem No Device Output (1435)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.(b)(6) 2020.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.

Event Description

The customer reported v60 blower has no output.There was no patient involvement.

Manufacturer Narrative

The biomedical engineer reported that the v60 blower has no output and that the v60 blower does not increase from 3,000 rpm.It was then reported that the v60 had been removed from service.In a review of the service history record, the customer requested to close the case.It is unknown if the issue occurred while in clinical use.No patient or user harm was reported.Multiple good faith efforts (gfe) were made to obtain information regarding the patient context of use, repair, and operational status with no response from the reporter and cannot be determined.If additional information is later obtained, a supplemental report will be submitted.

Manufacturer Narrative

Additional information was received that the device was not being used for medical treatment; no further details were provided regarding the event.No patient or use.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11051332
• MDR Text Key: 223606087
• Report Number: 2031642-2020-04671
• 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: 10/14/2021

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 08/13/2021; 09/15/2021
• Supplement Dates FDA Received: 09/10/2021; 10/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2013
• 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