BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT SUV VACUUM STABILIZER SYSTEM, ST

    MDR report key: 4012749 · Received July 10, 2014

    Report

    Report Number
    2242352-2014-00764
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE ACROBAT SUV VACUUM STABILIZER SYSTEM, ST WAS LOCKING TO THE DRIVE AND HAD TO BE PRIED OFF TO REMOVE IT. IT WAS ABLE TO BE USED FOR THE LAST DISTAL. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405656 ACROBAT SUV VACUUM STABILIZER SYSTEM, ST CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC OM-9000S 25096128

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR