BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.

    MDR report key: 4222734 · Received August 6, 2014

    Report

    Report Number
    2242352-2014-00841
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. SINCE THIS IS AN OEM SUPPLIED DEVICE, A LOT HISTORY REVIEW IS NOT APPLICABLE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, THE DRIVE ON THE ULTIMA ACTIVATOR II REUSABLE DRIVE MECH. IS "STARTING TO STICK AND IS A LITTLE HARD TO CRANK". THE DEVICE WAS NOT BEING USED ON A PATIENT AND THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461389 ULTIMA ACTIVATOR II REUSABLE DRIVE MECH. CLAMP-LESS BEATING HEART DWS MAQUET CARDIOVASCULAR, LLC UA-5001

    Patients

    Seq Age Sex Outcome Treatment
    1