BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT-I STABILIZER

    MDR report key: 4122162 · Received September 18, 2014

    Report

    Report Number
    2242352-2014-01014
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 9, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE ACROBAT-I STABILIZER ARM DID NOT HOLD FIRMLY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579108 ACROBAT-I STABILIZER CLAMP-LESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC OM-10000

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR