BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4090460 · Received September 15, 2014

    Report

    Report Number
    2031642-2014-01033
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    August 20, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMED AND WAS NOT CHARGING THE BATTERY. THE CUSTOMER REPORTED THE VENTILATOR WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. DURING EVALUATION, THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) REPORTED THE VENTILATOR WOULD NOT TURN ON WHEN THE BATTERY WAS DISCONNECTED. THE FSE REPLACED THE POWER SUPPLY AND REPORTED THE VENTILATOR WAS OPERATIONAL. APPLICABLE FINAL TESTING WAS PERFORMED PER OPERATING SPECIFICATIONS AND PASSED. LOSS OF POWER DURING NORMAL VENTILATION OPERATION WHEN REQUIRED MAY BE DETRIMENTAL TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570031 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1