BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 281428 · Received June 12, 2000

    Report

    Report Number
    2027060-2000-00005
    Event Type
    Other
    Date Received
    June 12, 2000
    Date of Event
    May 19, 2000
    Report Date
    May 30, 2000
    Manufacturer
    ALMSA
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE ALM CUSTOMER SVC REP THAT AS THE OPERATING ROOM WAS BEING READIED FOR USE, AN ORTHOPEDIC TABLE WAS INADVERTENTLY RAISED INTO THE CEILING MOUNTED SURGICAL LIGHT, BREAKING THE MAIN ARM (PART NUMBER 82032) WHERE IT ATTACHES TO THE SHAFT. THE UPPER MAIN ARM, SPRING ARM AND "CUPOLA" FELL TO THE FLOOR. NO INJURIES WERE REPORTED. CUSTOMER REPORTED TO ALM PROJECT SPECIALIST THAT CUSTOMER FELT RESISTANCE AS CUSTOMER WAS PUMPING THE TABLE UP, BUT WITHOUT LOOKING CONTINUED TO PUMP THE TABLE UP, SUBSEQUENTLY BREAKING THE ARM AND CAUSING THE COMPONENTS TO FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM SURGICAL LIGHT FSY ALMSA 50015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other