BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1247383 · Received October 3, 2008

    Report

    Report Number
    9710055-2008-00013
    Event Type
    Other
    Date Received
    October 3, 2008
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    PMA / PMN Number
    k0707442
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE RUBBER BUMPER THAT CAME OUT IS ATTACHED TO THE BOTTOM END OF THE SUSPENSION STRUCTURE, AND HOLDS IN PLACE INSERTED IN A GROOVE. A MAQUET REP VISITED THE HOSP, TO EVALUATE THE DEVICE AND REPRODUCE THE PROBLEM WITH THE HOSP STAFF: WHEN LIGHTHEAD COLLIDES WITH THE CENTRAL AXEL WITH A PARTICULAR ANGLE, THE BUMPER MAY GET OUT OF ITS GROOVE AND MAY FALL AFTER REPEATED VIOLENT IMPACTS. WHEN THIS HAPPENS, IT IS VERY VISIBLE FROM A USER STAND POINT THAT THE BUMPER IS NOT SAFELY ATTACHED. IN THIS CASE, COLLISION OF THE LIGHT ASSEMBLY COMPONENTS DIRECTLY RESULTED IN THE BUMPER BECOMING DISLODGED. POWERLED USER MANUAL PROVIDES RECOMMENDATIONS TO POSITION THE LIGHTHEAD AND INDICATES: "THE SURGICAL LIGHT MUST BE PRE-POSITIONED PRIOR TO ANY PROCEDURE TO MINIMIZE SUBSEQUENT HANDLING. BY PRE-POSITIONING THE SURGICAL LIGHT APPROPRIATELY FOR EACH PROCEDURE, POTENTIAL INTERACTIONS WITH POSSIBLE OBSTACLES ARE LIMITED". THE DIAMETERS OF THE BUMPER THAT FELL AND THE CENTRAL AXEL WERE MEASURED AND FOUND CONFORM TO THEIR SPECS. THE MAQUET REP ON SITE REPAIRED THE UNIT AND INFORMED THE HOSP STAFF ABOUT THE CORRECT MANNER TO HANDLE THE LIGHT, AS WELL AS THE APPROPRIATE POSITIONING OF THE BUMPER. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET PROVIDES PROD FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1