BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET HEART LUNG MACHINE HL20

    MDR report key: 2324724 · Received October 20, 2011

    Report

    Report Number
    8010762-2011-00011
    Event Type
    Malfunction
    Date Received
    October 20, 2011
    Date of Event
    September 23, 2011
    Report Date
    October 18, 2011
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K943503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOVASCULAR U.S. SALES LLC SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MFR OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). MFR. REFERENCE NUMBER: (B)(4). A FIELD UPDATE WAS INITIATED IN JUNE 2011 TO PREVENT PROBLEMS AS DESCRIBED ABOVE. WITH THE FIELD UPDATE, ALL CONSOLE/MAST INTERFACES WILL BE SEALED. ADDITIONALLY A COVER WILL BE MOUNTED OVER THE POWER SUPPLY BOARD INSIDE THE HL 20 CONSOLE. IN THE VERY UNLIKELY EVENT THAT LIQUID WILL FIND ITS WAY INTO THE CONSOLE, THE INSTALLATION OF THIS COVER WILL PREVENT THESE FLUIDS COMING INTO CONTACT WITH THE POWER CIRCUIT BOARD. THE FIELD UPDATE WAS NOT PERFORMED ON THE AFFECTED DEVICE IN INDIA. IN THE USA THE FIELD UPDATE IS ALREADY COMPLETED. MCV RECALL NUMBER: 8010762-2011-06-1002.

    Description of Event or Problem · 1

    DURING AN OPERATION, THE OPERATOR NOTICED A BURNING SMELL COMING FROM THE DEVICE. THERE IS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET HEART LUNG MACHINE HL20 DTQ MAQUET CARDIOPULMONARY AG HL20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other