BEUDAMED
    FDA Adverse Event Other Summary report: N

    9710055-2008-00006

    MDR report key: 1130643 · Received August 8, 2008

    Report

    Report Number
    9710055-2008-00006
    Event Type
    Other
    Date Received
    August 8, 2008
    Product Code
    FSY
    PMA / PMN Number
    K982063
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE REQUEST OF MAQUET SA, A NEW CAP WAS SENT TO THE CUSTOMER IN ORDER TO CHECK THE FIT OF THE CAP ON THE SURGICAL LIGHT. WE JUST RECEIVED INFO SPECIFIC TO THIS EVAL. THE RESULTS INDICATE THE ORIGINAL AND NEW CAP SENT WERE BOTH ABLE TO BE PROPERLY SEATED. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENT IS THE RUBBER END CAP WAS IMPROPER SEATING AFTER MAINTENANCE. MAQUET SA MAINTENANCE PROGRAM RECOMMENDATIONS INCLUDES REGULAR INSPECTION OF ALL PLASTIC COVERS AND CAPS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1