BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPOSE 4 DEVICE

    MDR report key: 2201643 · Received August 4, 2011

    Report

    Report Number
    2242352-2011-01074
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 20, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    DXC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING INVESTIGATED AND THE RESULTS ARE BEING EVALUATED AND ANALYZED WITH SIMILAR EVENTS. A F/U REPORT WILL BE SUBMITTED ONCE THE DEVICE EVAL IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE XPOSE 4 SUCTION CUP WAS DETACHED FROM THE FLEX-LINK ARM AT THE TIME OF OPENING THE DEVICE FROM THE PACKAGE. A COMPETITOR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPOSE 4 DEVICE CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR XP-4000 25021082

    Patients

    Seq Age Sex Outcome Treatment
    1 NA