BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 1552566 · Received November 25, 2009

    Report

    Report Number
    9710055-2009-00016
    Event Type
    Other
    Date Received
    November 25, 2009
    Date of Event
    September 30, 2009
    Report Date
    October 27, 2009
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    PMA / PMN Number
    K904965
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE MAQUET FIELD REP VISITED THE HOSPITAL AND REPLACED THE CAP THAT BROKE. THIS CAP IS LOCATED IN A PLACE OF THE LIGHT THAT CAN BE SUBJECTED TO IMPACTS WITH OTHER OBJECTS IN THE OPERATING ROOM. THE HOSPITAL IS UNDER PREVENTIVE MAINTENANCE WITH MAQUET. DURING THE LAST MAINTENANCE IN OCTOBER 2008, ONE MAQUET TECHNICIAN RECOMMENDED TO REPLACE THIS COVER BECAUSE IT WAS DAMAGED. THE HOSPITAL DID NOT FOLLOW THIS RECOMMENDATION. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET S.A. PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    AFTER A SURGERY, WHILE THE SURGICAL LIGHT SYSTEM WAS MOVED, A PLASTIC CAP OF THE BRACKET BROKE AND FELL TO THE FLOOR. THERE WAS NO PT IN THE ROOM, THE HOSPITAL DID NOT REPORT ANY INJURIES. (B) (4). (B) (4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1