BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT SUV VACUUM STABILIZER SYSTEM, ST

    MDR report key: 2093426 · Received April 12, 2011

    Report

    Report Number
    2242352-2011-00255
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    MWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE ACROBAT STABILIZER MAQUET LOGO PLATE POPPED OFF, OUTSIDE THE CHEST. THEY CONTINUED BY REPLACING THE LOGO USING THE PRODUCT. THERE WERE NO PT EFFECTS. THE PRODUCT WAS DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA