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

Model Number V60

Device Problem Failure to Calibrate (2440)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 12aug2020.

Event Description

The customer reported proximal pressure auto zero alarm failure.The customer duplicated the issue when running on a test lung for 15 min.The customer advised +35 volt failure, over voltage protection circuit failed, machine pressure sensor calibration data error, oxygen (o2) flow sensor calibration data error, air flow sensor calibration data error, o2 pressure sensor calibration data error, machine and proximal pressure sensors failed, proximal pressure sensor calibration data error, machine pressure sensor calibration data errors were in the significant event log.The customer checked pin alignment between the data acquisition (da) printed circuit board (pcb) and solenoids and found a bent pin.The device did not have patient involvement at the time the issue was discovered, therefore, there was no patient or user harm reported.

Manufacturer Narrative

G4:03feb2021.B4:04feb2021.The customer advised the remote service technician that the replaced solenoids and da pcb still had the same issue.The manufacture's remote service technician advised the customer to check the ribbon cable on the da pcb to motor controller (mc) pcb to make sure seated properly and advised the customer to double-check make sure pins are seated properly.The customer emailed the remote service engineer and indicated she reseated the cables and the boards, taking much extra care to ensure they went onto the pins correctly.After these steps, the customer reported no pressure sensor errors have returned.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: 10399483
• MDR Text Key: 203481588
• Report Number: 2031642-2020-02763
• 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
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2016
• 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