BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALM

    MDR report key: 234050 · Received July 28, 1999

    Report

    Report Number
    2027060-1999-00012
    Event Type
    Malfunction
    Date Received
    July 28, 1999
    Date of Event
    June 29, 1999
    Report Date
    June 30, 1999
    Manufacturer
    ALM SA/PARC DE LIMERE
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE ALM PROJECT SPECIALIST THAT A LIGHT IN AN ORTHOPEDIC PROCEDURES ROOM BEGAN FALLING AT THE SUSPENSION ARM FROM THE EXTENSION TUBE. THE LIGHT WAS HELD IN PLACE WITH AN IV POLE TO FINISH THE CASE. AFTER THE CASE WAS COMPLETED AND THE IV POLE REMOVED, THE LIGHT EVENTUALLY DETACHED COMPLETELY FROM THE EXTENSION TUBE. ALM PROJECT SPECIALIST WENT TO THE FACILITY THE FOLLOWING DAY TO INSPECT THE LIGHT. THE OUT OF WARRANTY LIGHT HAD ALREADY BEEN REPAIRED BY CONTRACTED MAINTENANCE PERSONNEL FROM ANOTHER MFR WHO OWNS A PERFORMANCE MAINTNANCE CONTRACT WITH THE FACILITY. COPY OF THE WORK ORDER WRITTEN BY THE MAINTENANCE PERSONNEL INDICATES THE LIGHT WAS BROKEN AT THE SHAFT. ALM HAS REQUESTED THE DAMAGED PARTS BE RETURNED FOR EVALUATION. DUE TO THE FACT THAT THE DAMAGED LIGHT WAS INSTALLED IN AN ORTHOPEDIC PROCEDURES ROOM, COMBINED WITH THE INFO INDICATING A BROKEN SHAFT, ALM SPECULATES THAT AT SOME TIME DURING IT'S USE, THE LIGHT WAS INADVERTENTLY STRUCK BY A CLT. ORTHOPEDIC TABLE. THE HOSPITAL CONFIRMED THAT THEY OWN SUCH A TABLE TO PERFORM ORTHOPEDIC PROCEDURES, HOWEVER, THEY COULD NOT PROVIDE INFO REGARDING ITS LAST USE IN THE ROOM WHERE THE DEVICE WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM SURGICAL LIGHT FTD ALM SA/PARC DE LIMERE 550012 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other