BEUDAMED
    FDA Adverse Event Other Summary report: N

    9710055-2008-00009

    MDR report key: 1227924 · Received August 14, 2008

    Report

    Report Number
    9710055-2008-00009
    Event Type
    Other
    Date Received
    August 14, 2008
    Product Code
    FTD
    PMA / PMN Number
    k895715
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET SVC REP VISITED THE HOSP, AND EVALUATED THE SURGICAL LIGHT. HE FOUND THAT YOKES, ARMS AND CUPOLAS IN OR #6 AND OTHERS SHOW COLLISION DAMAGE. A LARGE AREA OF THE YOKE SURFACE IS MISSING PAINT. THE HLX LIGHT OPERATING MANUAL PROVIDES RECOMMENDATIONS TO POSITION THE LIGHT HEADS DURING SURGERIES. THE MAQUET SVC TEAM ON SITE INSTRUCTED HOSP STAFF IN THE PROPER HANDLING OF THE LIGHTS IN ORDER TO AVOID COLLISIONS DURING USE. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET. PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FTD

    Patients

    Seq Age Sex Outcome Treatment
    1