BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT-I STABILIZER

    MDR report key: 3001917 · Received February 12, 2013

    Report

    Report Number
    2242352-2013-00081
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Report Date
    January 21, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY BYPASS PROCEDURE, THE ACROBAT-I STABILIZER WAS STICKING WHEN IT WAS MOVED LATERALLY. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. THE HOSP INTENDS TO RETURN THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62168 ACROBAT-I STABILIZER CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC OM-10000 25062678

    Patients

    Seq Age Sex Outcome Treatment
    1 NA