BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP SYSTEM

    MDR report key: 4931130 · Received July 22, 2015

    Report

    Report Number
    8010762-2015-00588
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Report Date
    July 16, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K102726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEM, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). THE DEVICE WAS EVALUATED BY THE SSU AND THE HMI BOARD WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE SSU REPRESENTATIVE A MAQUET CARDIOVASCULAR LLC. IN WAYNE NJ REPORTED THAT CARDIOHELP-I SERIAL NUMBER (B)(4) HAD A TOUCH SCREEN CALIBRATION PROBLEM. THE BOTTOM OF THE SCREEN WAS NOT WORKING WHEN TRYING TO SELECT A BUTTON. CALIBRATION WAS ATTEMPTED MULTIPLE TIMES BUT WAS NOT SUCCESSFUL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475388 CARDIOHELP SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG 70104.8012

    Patients

    Seq Age Sex Outcome Treatment
    1