BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT SUV VACUUM STABILIZER SYSTEM, ST

    MDR report key: 2180757 · Received April 29, 2011

    Report

    Report Number
    2242352-2011-00377
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    April 5, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DWS
    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

    INVESTIGATION: THE PRODUCT WILL NOT BE RETURNED TO MAQUET FOR INVESTIGATION. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. A LOT HISTORY RECORD REVIEW COULD NOT BE COMPLETED AS THE PRODUCT LOT NUMBER IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE ACROBAT SUV STABILIZER LOGO DETACHED OUTSIDE THE PATIENT. THE SAME UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACROBAT SUV VACUUM STABILIZER SYSTEM, ST ACROBAT SUV DWS MAQUET CARDIOVASCULAR, LLC OM-9000S NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA