BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 1647997 · Received March 26, 2010

    Report

    Report Number
    9710055-2010-00008
    Event Type
    Other
    Date Received
    March 26, 2010
    Date of Event
    February 24, 2010
    Report Date
    February 24, 2010
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    PMA / PMN Number
    K040735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHTHEAD IS SECURED TO THE SPRING 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, A YELLOW LABEL STATING THAT "THE SLEEVE MUST BE SECURED BY SCREW" IS PLACED DIRECTLY ON THE SPRING ARMS. ADDITIONAL INSTRUCTIONS AND WARNINGS ARE ALSO INCLUDED IN THE XTEN INSTALLATION AND SERVICE MANUALS. A MAQUET FIELD REPRESENTATIVE 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. HE ALSO VERIFIED ALL SIMILAR UNITS IN THIS FACILITY.

    Description of Event or Problem · 1

    DURING CLEANING OF THE SURGICAL LIGHT, THE LAMP HEAD STARTED TO FALL DOWN, BUT COULD BE RETAINED BY THE EMPLOYEE. THE HOSPITAL DID NOT REPORT ANY INJURIES. (B) (4). (B) (4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1