BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET

    MDR report key: 1633001 · Received March 12, 2010

    Report

    Report Number
    9710055-2010-00006
    Event Type
    Injury
    Date Received
    March 12, 2010
    Date of Event
    February 11, 2010
    Report Date
    February 11, 2010
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LED LIGHT HEAD IS SECURED TO THE MAIN ARM VIA A RETAINING CLIP. THIS CLIP IS KEPT IN PLACE BY A PROTECTIVE COVER/SLEEVE WHICH IN TURN IS SECURED TO THE LIGHTING UNIT BY A SCREW TO PREVENT ITS MOVEMENT. MANUFACTURER ANALYSIS FOUND THAT THE SAFETY COVER WAS NOT INSTALLED PROPERLY ON THIS LIGHTING UNIT. THE COVER WAS MISSING ITS FASTENING SCREW. BECAUSE THIS SCREW WAS MISSING, THE COVER WAS ABLE TO SLIDE OUT OF POSITION AND THE RETAINING CLIP WORKED ITS WAY LOOSE ALLOWING THE CUPOLA ASSEMBLY TO FALL. TO PREVENT THIS TYPE OF OCCURRENCE, MAQUET PLACES YELLOW LABELS DIRECTLY ON THE SPRING ARMS STATING THAT "THE SLEEVE MUST BE SECURED BY SCREW". ADDITIONAL INSTRUCTIONS AND WARNINGS ARE ALSO INCLUDED IN THE POWERLED INSTALLATION AND SERVICE MANUALS. MAQUET (B) (4) HAS FACILITATED A REPAIR OF THIS LIGHT ENSURING THAT THE LOCKING PIN IS IN PLACE AND THAT THE RETAINING SLEEVE IS SECURED PROPERLY IN CORRECT POSITION. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET S.A. PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    CLEANING STAFF MEMBER WAS CLEANING THE OPERATING ROOM LIGHTS. WHEN SHE PULLED THE CUPOLA HANDLE TOWARDS HER TO CLEAN THE CUPOLA, THE CUPOLA DISENGAGED FROM THE SPRING ARM, AND STRUCK THE CLEANING STAFF MEMBER MID-FACE. THE CUPOLA THEN LANDED ON THE FLOOR. THE CUPOLA FRACTURED THE STAFF MEMBER'S NOSE, AND BROKE HER EYEGLASSES. (B) (4)

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other