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

Model Number V60

Device Problem Failure to Run on Battery (1466)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 21aug2020.

Event Description

The service technician reported that when the ac power was removed and the unit was powered on using the battery power, the unit will not turn on.The service technician reported that in case ac power was selected, the device was capable of functioning as usual.The customer reported that the unit was not in use on a patient.

Manufacturer Narrative

Date rec'd by mfr: 23dec2020.Date of report: 31dec2020.Besides the battery replacement.The user interface board was also replaced to resolve the issue of the unit starting up on it own.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: 04nov2020, b4: 20nov2020.The service technician replaced the battery to address the reported problem.During review of the diagnostic report (drpt) it was confirmed the unit started up by itself, so the investigation is ongoing.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: 10438379
• MDR Text Key: 204221880
• Report Number: 2031642-2020-02886
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 884838033832
• UDI-Public: (01)884838033832
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• 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: 07/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2018
• 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