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

Model Number V60

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 18aug2020.

Event Description

After replacing the power supply, the customer saw smoke coming from the data acquisition board.There was no patient involvement.The customer checked the significant event log and reported to the remote service engineer that he saw numerous error codes.

Manufacturer Narrative

G4: 22oct2020.B4: 23oct2020.The numerous error codes reported by the customer were machine pressure sensor calibration data error.Backup alarm failed and proximal pressure sensor calibration data error.The device was sent for bench repair and the service technician confirmed the reported problem.They found that the cable between the motor controller pcba (printed circuit board assembly) and data acquisition pcba were plugged in upside down and burned the data acquisition pcba.The unit would show error code "machine and proximal pressure sensors failed" on boot up.After trying a different data acquisition pcba, unit would boot up to errors "air flow sensor calibration data error." and "oxygen flow sensor calibration data error".The service technician replaced the gds (gas delivery system) and the reported problem was resolved.The ventilator was calibrated successfully and passed all required 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

G4:09feb2021.B4:17feb2021.A gas delivery system (gds) was returned for analysis.A visual inspection of the returned component was performed, and the cable between the motor controller pcba (printed circuit board assembly) and data acquisition pcba were plugged in upside down.As a result, extensive damage was found on the daq board.The returned component was installed into a test ventilator for analysis.The product analysis technician reported that the root cause was determined to be external electrical stress.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: 10422862
• MDR Text Key: 203874968
• Report Number: 2031642-2020-02835
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• 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: 01/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2018
• 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