BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 286378 · Received July 19, 2000

    Report

    Report Number
    2027060-2000-00007
    Event Type
    Other
    Date Received
    July 19, 2000
    Date of Event
    June 23, 2000
    Report Date
    July 6, 2000
    Manufacturer
    ALM SA
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT A PORTABLE SURGICAL LIGHT TIPPED OVER WHILE IN USE AND FELL ONTO A PT. THE LIGHT INVOLVED IN THE INCIDENT IS ALM PROPERTY AND WAS IN THE CUSTOMER FACILITY FOR DEMONSTRATION / EVAL. A USER MANUAL WAS NOT LEFT WITH THE CUSTOMER. THE NURSE REPORTED TO THE ALM CONTRACTED TECHNICAL REP THAT THE CASTERS WERE LOCKED WHEN NURSE ATTEMPTED TO MOVE THE LIGHT INTO A BETTER POSITION. WHEN NURSE RELEASED THE LIGHT IT CONTINUED TO FAIL AND STRUCK THE PT ON THE LEFT SHIN. THE PT SUSTAINED BRUISING AND ABRASIONS WHICH WERE TREATED BY ELEVATION AND APPLICATION OF ICE PACKS. THE ALM CONTRACTED TECHNICAL REP INSPECTED THE LIGHT ON 6/26/00 AND FOUND THAT IT WAS ASSEMBLED CORRECTLY AND IN GOOD WORKING ORDER. HE PROVIDED ADDITIONAL IN-SERVICE INSTRUCTIONS TO THE CUSTOMER REGARDING THE MOVEMENT AND POSITIONING OF THE PORTABLE LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM PORTABLE SURGICAL LIGHT FSY ALM SA 50025 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention