BEUDAMED
    FDA Adverse Event Other Summary report: N

    9710055-2007-00010

    MDR report key: 970743 · Received April 4, 2007

    Report

    Report Number
    9710055-2007-00010
    Event Type
    Other
    Date Received
    April 4, 2007
    Product Code
    FSY
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE CEILING COVER CLAMP RING WAS BROKEN DUE TO EXCESSIVE TIGHTENING (TORQUE > 0.25 N/M) OF THE TWO ATTACHMENT SCREWS. PRIOR TO THE INCIDENT, THE LAST MAQUET PERFORMED MAINTENANCE RECORD ON THIS SURGICAL LIGHT DATES BACK TO 11/04. AS FOLLOW-UP, AN INTEGRITY CHECK OF EACH HLX 2000 CLAMP RING USED AT THE FACILITY WAS PERFORMED. REPLACEMENTS WERE MADE, WHEN NECESSARY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1