BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 4102588 · Received August 27, 2014

    Report

    Report Number
    9710055-2014-00066
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    Manufacturer
    MAQUET S.A.S
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO TESTS PERFORMED DURING DESIGN VERIFICATION ACTIVITIES, THIS TYPE OF FAILURE CAN BE CAUSED BY REPEATED COLLISIONS/IMPACTS TO THE CUPOLA. THE POWERED SERIES OPERATING MANUAL INCLUDES A VERIFICATION OF ALL THE COVERS DURING YEARLY MAINTENANCES. A MAQUET FIELD SERVICE TECHNICIAN WILL VISIT THE FACILITY IN ORDER TO REPLACE AND SECURE THE END-CAP. MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG 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 FELL OFF IN THE STERILE FIELD. THE BUMPER DID NOT FALL INTO THE PT. NO INJURIES WERE REPORTED TO MAQUET. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519001 POWERLED FSY MAQUET S.A.S PWD73+SF R K3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA