BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 1943110 · Received December 30, 2010

    Report

    Report Number
    2031642-2010-00347
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRINTED CIRCUIT BOARD (PCB).

    Description of Event or Problem · 1

    DURING DEMONSTRATION OF THE DEVICE, THE MANUFACTURER'S SALE REPRESENTATIVE REPORTED THE UNIT HAD NO AIR FLOW WHEN POWERED ON, AND WAS ALARMING DUE TO AN OCCLUSION. THE SALES REP POWERED THE UNIT OFF AND ON WITH THE SAME RESULT OF NO FLOW AND AN OCCLUSION ALARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED EVENT. THE SERVICE TECHNICIAN REPORTED THE MOTOR WOULD NOT OPERATE AND REPLACED THE MOTOR CONTROLLER PCB BOARD. TESTING WAS PERFORMED AND REPORTED PASSED.

    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