BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2863610 · Received December 10, 2012

    Report

    Report Number
    2031642-2012-00532
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 30, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR HAD A POWER FAIL OCCURRENCE. THE MANUFACTURER SERVICE TECH NOTED A BURNING SMELL AND THE 1000 ERROR CODE. THE MANUFACTURER SERVICE TECH REPLACED THE CPU PCB, UI DISPLAY ASSEMBLY AND MOTOR CONTROLLER BOARD. IF A VENT INOP OCCURS DURING USE, THE USER MUST IMMEDIATELY SECURE ALTERNATIVE MEANS OF VENTILATION FOR THE PATIENT. THE VENTILATOR WAS NOT IN USE ON A PATIENT, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT OR HARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1