BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT SUV VACUUM STABILIZER SYSTEM, ST

    MDR report key: 2081877 · Received April 5, 2011

    Report

    Report Number
    2242352-2011-00229
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 8, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE LOGO PLATE HAD DETACHED. THERE WAS EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "LOGO PLATE CAME OFF DURING USE" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE ACROBAT STABILIZER MAQUET LOGO PLATE CAME OFF DURING USE. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACROBAT SUV VACUUM STABILIZER SYSTEM, ST ACROBAT SUV MWS MAQUET CARDIOVASCULAR, LLC. OM-9000S 25017852

    Patients

    Seq Age Sex Outcome Treatment
    1 NA