BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 5313576 · Received September 27, 2004

    Report

    Report Number
    9710053-2004-00005
    Event Type
    Other
    Date Received
    September 27, 2004
    Report Date
    September 10, 2004
    Manufacturer
    ALM S.A.
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHT SYSTEM WAS EVALUATED BY GETINGE SERVICE REPRESENTATIVE AND IT WAS DETERMINED THAT THE SNAP RING MAY NOT HAVE BEEN FULLY SEATED. THE SPRING ARM WAS REINSTALLED AND SNAP RING CHECKED FOR PROPER FIT. A NEW LIGHTHEAD WAS ORDERED FOR THE CUSTOMER.

    Description of Event or Problem · 1

    LIGHT HEAD AND ARM FELL TO THE FLOOR DURING THE NIGHT. THERE WERE NO INJURIES OR WITNESSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM SURGICAL LAMP FTD ALM S.A. AX4

    Patients

    Seq Age Sex Outcome Treatment
    1