BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 1792558 · Received August 11, 2010

    Report

    Report Number
    2031642-2010-00210
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRINTED CIRCUIT BOARD (PCB).

    Description of Event or Problem · 1

    WHILE ONSITE FOR SERVICE, THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE VENTILATOR WOULD NOT POWER ON. THE VENTILATOR WAS NOT IN USE ON A PATIENT, THEREFORE THERE WAS NO PATIENT HARM OR INVOLVEMENT. REVIEW OF THE VENTILATOR DIAGNOSTIC LOG NOTED A 35VOLT FAILURE OCCURRENCE WHICH MAY RESULT IN A SHUT DOWN OF THE DEVICE DURING OPERATION. THERE WAS NO REPORT FROM THE USER REGARDING AN OCCURRENCE OF THE VENTILATOR NOT POWERING ON AS REPORTED. THE SERVICE TECHNICIAN REPLACED THE CPU PCB BOARD TO COMPLETE THE REPAIR. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS PASSED TO OPERATING SPECIFICATIONS.

    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