BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 11197314 · Received January 19, 2021

    Report

    Report Number
    2031642-2021-00207
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Report Date
    September 7, 2021
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATA ACQUISITION BOARD (DAQ) WAS RETURNED FOR FAILURE EVALUATION. THE FAILURE INVESTIGATION TECHNICIAN TESTED THE DAQ BOARD AND NO FAULT WAS FOUND. THE ISSUE COULD NOT BE REPLICATED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2020. DATE OF REPORT: 19JAN2021.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAD A PROXIMAL PRESSURE SENSOR CALIBRATION DATA ERROR. THE DEVICE WAS NOT IN USE AT THE TIME OF THE EVENT. THIS WAS A DEVICE THAT WAS IN THE STOCK IN PHILIPS (B)(6) AND WAS NOT USED FOR THERAPY. THE ERROR OCCURRED WHILE THE DEVICE WAS IN THE SALES OFFICE. THE PHILIPS SERVICE TECHNICIAN EVALUATED THE VENTILATOR AND CONFIRMED THE ERROR LOG HAD ERROR CODE (MACHINE AND PROXIMAL PRESSURE SENSOR) AND ERROR CODE (PROXIMAL PRESSURE SENSOR AUTO ZERO FAILED) HAD OCCURRED. THE PHILIPS SERVICE TECHNICIAN REPLACED THE DATA ACQUISITION BOARD TO RESOLVE THE ISSUE. THE DEVICE SUCCESSFULLY PASSED ALL REQUIRED TESTING, AND REMAINS AT THE CUSTOMER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93614 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60

    Patients

    Seq Age Sex Outcome Treatment
    1