BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET

    MDR report key: 1660557 · Received April 14, 2010

    Report

    Report Number
    9710055-2010-00009
    Event Type
    Other
    Date Received
    April 14, 2010
    Date of Event
    March 11, 2010
    Report Date
    March 11, 2010
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    PMA / PMN Number
    K040735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET FIELD SERVICE TECHNICIAN (FST) VISITED THE CUSTOMER AND EVALUATED THE DEVICE. THE FST REPORTED THAT SEVERAL DEVICES ARE ATTACHED TO THE CEILING, ALL AROUND THE SURGICAL LIGHT SYSTEM. AMONG THESE DEVICES IS THE ONE THAT HIT THE SURGICAL LIGHT. THE SERVICE TECH DETERMINED THAT THIS DEVICE IS EQUIPPED WITH ROTATION STOPS, BUT THE STOPS WERE NOT SET CORRECTLY ON THIS UNIT AND THEREFORE COLLISIONS WITH THE LIGHT WERE POSSIBLE. THE FST REPAIRED THE BROKEN PARTS OF THE LIGHT, ADJUSTED THE ROTATION STOPS ON THE OTHER DEVICE IN ORDER TO AVOID FUTURE COLLISIONS, AND VERIFIED THE OTHER OPERATING ROOMS IN THE HOSPITAL. 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

    DURING A CASE, THE SURGICAL LIGHT SYSTEM WAS STRUCK BY ANOTHER MEDICAL DEVICE. THIS IMPACT SHEARED THE NYLON SCREWS USED TO SECURE THE LIGHT'S CEILING COVER, ALLOWING ONE OF THE METAL COVERS TO FALL TO THE FLOOR. THE PIECE DIDN'T HIT ANYBODY IN THE ROOM. (B) (4). (B) (4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1