BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HL-20 TWIN PUMP

    MDR report key: 4944784 · Received July 28, 2015

    Report

    Report Number
    8010762-2014-00914
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    September 5, 2013
    Report Date
    September 5, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DPW
    PMA / PMN Number
    K984338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 A (B)(4) TECHNICIAN AND THE OPTICAL TACHO BOARD, MOTOR BELT AND BELT PULLEY WERE REPLACED AND THE ISSUE WAS RESOLVED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED BY THE (B)(4) AT MAQUET MEDICAL (B)(4) THROUGH THE MSUPPORT SYSTEM COMPLAINT NUMBER (B)(4) THAT THE TPM 20-330 TWIN ROLLER PUMP MODULE SERIAL NUMBER (B)(4) DISPLAYED A BELTSLIP ERROR WHEN RUNNING AT 250 RPM BUT THE DISPLAY INDICATED 119 RPM. THE RPM WAS MEASURED WITH AN EXTERNAL TACHOMETER AND IT INDICATED 119 RPM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489968 HL-20 TWIN PUMP FLOWMETER, BLOOD, CARDIOVASCULAR DPW MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1