BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT-I STABILIZER

    MDR report key: 3813587 · Received March 26, 2014

    Report

    Report Number
    2242352-2014-00335
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 25, 2014
    Report Date
    March 3, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNK. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT AFTER A CORONARY ARTERY BYPASS PROCEDURE, THE BLADES WOULDN'T DETACH FROM THE RETRACTOR. THE DEVICE WAS USED OT COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176646 ACROBAT-I STABILIZER CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC OM-10000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI