BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOPRO

    MDR report key: 2994418 · Received March 1, 2013

    Report

    Report Number
    MW5029256
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEMOPRO DEVICE WAS DEFECTIVE. SMOKE WAS COMING FROM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89117 HEMOPRO HEMOPRO GEI MAQUET CARDIOVASCULAR UH-3000 25065864

    Patients

    Seq Age Sex Outcome Treatment
    1