BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4150295 · Received October 7, 2014

    Report

    Report Number
    2031642-2014-01161
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Report Date
    September 9, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WILL NOT POWER UP. THE CUSTOMER REPORTED THAT THE UNIT WAS NOT IN USE ON PATIENT. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE UNIT AND DUPLICATED THE CUSTOMER REPORTED PROBLEM. THE FSE REPLACED THE CPU BOARD AND PM BOARD TO ADDRESS THE REPORTED ISSUE. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628628 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1