BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET CARDIOPULMONARY AG

    MDR report key: 3856737 · Received February 12, 2014

    Report

    Report Number
    8010762-2014-00049
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 15, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF NEW INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE PUMP ON THE HEART LUNG MACHINE WAS DISPLAYING A 'RUN-AWAY" ERROR ABOVE 15RPM. NO PT INJURY. REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94125 MAQUET CARDIOPULMONARY AG HL 20 4-PUMPS CONSOLE BASE DTQ MAQUET CARDIOPULMONARY AG NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI