BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 4945154 · Received July 24, 2015

    Report

    Report Number
    2021710-2015-01267
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 26, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR IN (B)(6) DETERMINED THAT THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS THAT THE DEVICE'S MAIN PCBA WAS MALFUNCTIONING. THE DISTRIBUTOR IN (B)(6) WAS SHIPPED A REPLACEMENT MAIN PCBA TO REPAIR THE DEVICE AND RETURN IT TO SERVICE. CAREFUSION ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE DISTRIBUTOR IN CHINA FOR THE RETURN OF THE ALLEGED FAULTY MAIN PCBA FOR EVALUATION. AS OF THE (B)(6) 2015 THE ALLEGED FAULTY MAIN PCBA HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR IN (B)(6) REPORTED THAT WHEN TURNED ON THE DEVICE ALARMED "VENT INOP" AND "MOTOR FAULT". THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482645 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION VELA NA

    Patients

    Seq Age Sex Outcome Treatment
    1