BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 4874055 · Received June 25, 2015

    Report

    Report Number
    9710055-2015-00050
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    April 3, 2015
    Report Date
    May 27, 2015
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Removal / Correction Number
    Z-1730-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MALFUNCTION WAS PREVIOUSLY ADDRESSED IN THE U.S. THROUGH THE DEVICE CORRECTION. THE CUSTOMER'S REPAIR VENDOR IS ORDERING A NEW AMBIENT LIGHT MODULE AND WILL PERFORM THE REPAIR.

    Description of Event or Problem · 1

    CUSTOMER'S REPAIR VENDOR CONTACTED MAQUET TO ASK FOR A REPLACEMENT AMBIENT LIGHT MODULE SINCE THEY HAD A BROKEN ONE. THE HOUSING WAS CRACKED FROM A HIT AND HAD TEMPORARILY BEEN TAPED IN PLACE. THERE WAS NO PATIENT INVOLVED AND NO INJURIES WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411058 POWERLED FSY MAQUET S.A. PWD700SFVK3

    Patients

    Seq Age Sex Outcome Treatment
    1