BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED 700

    MDR report key: 7398934 · Received April 5, 2018

    Report

    Report Number
    9710055-2018-00016
    Event Type
    Malfunction
    Date Received
    April 5, 2018
    Date of Event
    March 14, 2018
    Report Date
    April 5, 2018
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074. EXEMPTION # E2018005. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: PEDRO CRUZ. ON THE 14TH OF MARCH, 2018 MAQUET SAS BECAME AWARE OF AN INCIDENT WITH SPRING ARM OF POWERLED 700 DEVICE. AS STATED IN THE COMPLAINT, BLACK GRIT WAS COMING FROM THE POWERLED 700 FORK WHERE IT PLUGS INTO THE SPRING ARM. THE MALFUNCTION WAS INDICATED TO HAVE OCCURRED IN THE OPERATING ROOM AND NO INJURY WAS REPORTED. THERE WAS NO EXACT INDICATION WHEN THE MALFUNCTION OCCURRED. DURING THE INVESTIGATION IT WAS FOUND THAT THERE IS NO APPARENT TREND WITH THIS ISSUE. UNFORTUNATELY, DUE TO THE LIMITED INFORMATION AVAILABLE, WE WERE NOT ABLE TO ESTABLISH THE EXACT ROOT CAUSE AND SEQUENCE OF EVENTS WHICH HAVE LED TO THE ISSUE COVERED BY THIS INVESTIGATION. GETINGE WILL CONTINUE TO MONITOR SIMILAR PROBLEMS AND WILL UPDATE IF IT ARISES.

    Description of Event or Problem · 0

    ON THE 14TH OF MARCH, 2018 MAQUET (B)(4) BECAME AWARE OF AN INCIDENT WITH SPRING ARM OF POWERLED 700 DEVICE. AS STATED IN THE COMPLAINT, ¿¿A CALL FROM THIS FACILITY WAS RECEIVED COMPLAINING OF BLACK GRIT COMING FROM THE 700 FORK WHERE IT PLUGS INTO THE SPRING ARM.¿¿THE MALFUNCTION OCCURRED IN THE OPERATING ROOM, NO DEATH OR INJURY WAS REPORTED.DESPITE OF EFFORTS IN GATHERING MORE INFORMATION REGARDING THE EVENT, NONE HAVE BEEN PROVIDED BY THE ORIGINATOR. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244137 POWERLED 700 LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1