BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMATIC

    MDR report key: 4961933 · Received July 31, 2015

    Report

    Report Number
    9710055-2015-00062
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 3, 2015
    Report Date
    July 3, 2015
    Manufacturer
    MAQUET S.A.S
    Product Code
    FTD
    PMA / PMN Number
    K882613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET (B)(4) VISITED THE FACILITY, AND MET WITH THE CUSTOMER. THEY DETERMINED THAT THIS EVENT IS DUE TO THE AGE OF THE LIGHT (20+ YEARS OLD) AND THE ARMS CONSTANTLY COLLIDING AGAINST ONE ANOTHER FOR MANY YEARS. THE CUSTOMER HAS COVERED AREAS OF THE LIGHT WHERE THE CHIPPING IS AT ITS WORST. THE PRISMATIC SERIES YEARLY PREVENTIVE MAINTENANCE PROGRAM INCLUDES A VERIFICATION OF THE "PAINTING CONDITION, ESPECIALLY IN THE EVENT OF SHOCKS".

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LIGHT HAS PAINT CHIPPING OFF OF THE SPRING ARM AND MAIN ARM DUE TO IMPACT WITH THE DOWNTUBE AND OTHER MAIN ARMS. THE HOSPITAL HAS BEEN EXPERIENCING SOME PAINT CHIPS FALLING ONTO OPERATION ROOM FLOOR AND INTO THE STERILE FIELD DURING CERTAIN PROCEDURES. NO INJURIES WERE REPORTED. (B)(4). MAQUET IS AWARE OF A TOTAL OF 6 SIMILAR EVENTS INVOLVING 6 SEPARATE DEVICES. THESE 6 EVENTS ARE BEING REPORTED IN THE MDR'S #9810055-2015-00060 THROUGH 9710055-2015-00065.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498913 PRISMATIC FTD MAQUET S.A.S PRC

    Patients

    Seq Age Sex Outcome Treatment
    1