BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1822650 · Received September 1, 2010

    Report

    Report Number
    2031642-2010-00248
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    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.

    Description of Event or Problem · 1

    FACTORY ANALYSIS OF A RETURNED CPU PCB BOARD REVEALED A MALFUNCTION THAT RESULTED IN A VENTILATOR RESTART DURING TESTING. IF A RESTART OF THE VENTILATOR OCCURS DURING USE, AN AUDIBLE ALARM WILL ACTIVATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1