BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HL20 INTEGRATED PERFUSION SYSTEM

    MDR report key: 5836647 · Received August 1, 2016

    Report

    Report Number
    8010762-2016-00493
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    July 11, 2016
    Report Date
    July 14, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE ISSUE HAS BEEN REEVALUATED WITH THE RESULT THAT THIS ISSUE "EPROM ERROR ON HL20" IS NOT REPORTABLE. AS THE EPROM ERROR IS PART OF THE SELF TEST OF THE HL20, WHICH IS ALWAYS PERFORMED PRIOR TO USE (DURING STARTUP OF THE DEVICE, AND THE EPROM IS NOT TESTED AT ANY LATER POINT IN TIME, IT CAN BE EXCLUDED THAT THE ERROR WILL OCCUR DURING PATIENT TREATMENT. ADDITIONAL BASED ON THE TREND SEARCH ANALYSIS NO COMPLAINT WAS FOUND WITH THE MENTIONED ISSUE HAPPENED DURING PATIENT TREATMENT. ALL RELATED ISSUES OCCURRED PRIOR TO USE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT "AFTER REPLACING THE BELTS AND ESD CABLE, THE UNIT DISPLAYED A EEPROM ERROR. THIS HAPPENED DURING PREVENTATIVE MAINTENANCE. NO PATIENT INVOLVED. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490976 HL20 INTEGRATED PERFUSION SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG 701028671

    Patients

    Seq Age Sex Outcome Treatment
    1