BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT SUV VACUUM SATBILIZER SYSTEM, ST

    MDR report key: 1883023 · Received October 15, 2010

    Report

    Report Number
    2242352-2010-03091
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    MWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON (B)(6), 2010, FOR INVESTIGATION. VISUAL INSPECTION REVEALED THAT THE MAQUET LOGO PLATE WAS DETACHED FROM THE DEVICE AND INTACT. THE DEVICE WAS BLOODY. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "MAQUET LOGO PLATE FELL OUT" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE MAQUET LOGO PLATE ON THE ACROBAT SUV VACUUM STABILIZER SYSTEM, ST FELL OUT WHEN THE USER WAS CRANKING ON THE DEVICE TO DO THE 1ST TIGHTENING. THE PIECE DID NOT FALL INTO THE PATIENT, SO NO RETRIEVAL WAS REQUIRED. A REPLACEMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA