BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2012474 · Received March 9, 2011

    Report

    Report Number
    2031642-2011-00059
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    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

    Description of Event or Problem · 1

    THE UNIT WOULD NOT POWER ON THROUGH POST, AND THE POWER SUPPLY WAS REPLACED TO CORRECT THE FINDING. FACTORY ANALYSIS OF THE POWER SUPPLY REVEALED A FINDING THAT WOULD RESULT IN THE LOSS OF THE +24V SUPPLY DURING OPERATION, WHICH WOULD RESULT IN A VENT INOP OCCURRENCE DURING NORMAL VENTILATOR MODE OPERATION. VENT INOP DURING USE WILL ALARM AND STOP PROVIDING VENTILATORY SUPPORT TO THE PATIENT.

    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