BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIRA-I CS RETRACTOR SYSTEM

    MDR report key: 3871300 · Received April 15, 2014

    Report

    Report Number
    2242352-2014-00442
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Report Date
    March 21, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    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. 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 THE DRIVE POSITION OF THE MIRA-I CS RETRACTOR SYSTEM ALONG THE STERNUM STICKS UP A LARGE AMOUNT WHEN THE RETRACTOR IS ENGAGED. ONCE THE RETRACTOR IS ENGAGED THE BLADES ANGLE TOWARDS EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230581 MIRA-I CS RETRACTOR SYSTEM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC MS-1000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI