BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT-I STABILIZER

    MDR report key: 2945480 · Received February 1, 2013

    Report

    Report Number
    2242352-2013-00041
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 10, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    MWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. 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 RECORD IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE ACROBAT-I STABILIZER FAILED TO MAINTAIN ITS POSITION ON THE HEART. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE HOSPITAL INTENDS TO RETURN THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44214 ACROBAT-I STABILIZER CLAMPLESS BEATING HEART MWS MAQUET CARDIOVASCULAR, LLC. OM-10000 25065430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA