BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOPRO2

    MDR report key: 3043027 · Received March 7, 2013

    Report

    Report Number
    2242352-2013-00202
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVAL CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO 2 DEVICE LOST POWER. THE CORDS WERE REPLACED; HOWEVER, THE DEVICE STILL DID NOT HAVE POWER. THE HEMOPRO 2 ADAPTOR WAS REPLACED AND THE DEVICE WORKED PROPERLY. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE HOSPITAL WILL REPORTED NOT BE RETURNING THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98374 HEMOPRO2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA