BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLED

    MDR report key: 3999214 · Received July 30, 2014

    Report

    Report Number
    9710055-2014-00058
    Event Type
    Injury
    Date Received
    July 30, 2014
    Report Date
    March 26, 2014
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN (FST) INSPECTED THE DEVICE AND FOUND NO VISIBLE DAMAGES IN THE END CAP. THE END CAP WAS REPLACED AND SECURED IN PLACE WITH 2 STAINLESS STEEL SCREWS. ACCORDING TO TESTS PERFORMED DURING DESIGN VERIFICATION ACTIVITIES, THIS TYPE OF FAILURE CAN BE CAUSED BY REPEATED COLLISIONS/IMPACTS TO THE CUPOLA. THE POWER LED SERIES OPERATING MANUAL INCLUDES A VERIFICATION OF ALL THE COVERS DURING YEARLY MAINTENANCES. MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET SAS PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE END CAP OF THE SURGICAL LIGHT IN OR 11 FELL OFF IN THE STERILE FIELD. NO INJURIES WERE REPORTED TO MAQUET. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446181 POWERLED FSY MAQUET SAS PWD75+SF V R K3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA