BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 225336 · Received May 26, 1999

    Report

    Report Number
    2027060-1999-00007
    Event Type
    Other
    Date Received
    May 26, 1999
    Date of Event
    April 30, 1999
    Report Date
    May 3, 1999
    Manufacturer
    ALM SA
    Product Code
    FTD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE WAS SHOCKED WHILE TOUCHING A FUSE HOLDER ON AN LDR SURGICAL LIGHT CONTROL BOX. ALTHOUGH NOT INJURED, THE NURSE REPORTEDLY SPENT THE NIGHT IN THE ER. ALM TECHNICAL SPECIALIST SENT IN A CONTRACTED TECHICAL REP TO EVALUATE THE DEVICE. IT WAS REPORTED TO HIM THAT THE NURSE WAS HAVING A PROBLEM WITH THE LIGHT RETRACTING INTO THE CEILING AND REMOVED THE CAP FROM THE FUSE HOLDER TO MAKE IT WORK. IT WAS DISCOVERED THAT THE SWTICH NECESSARY FOR OPERATING THE RETRACTION OF THE DEVICE WAS DEFECTIVE. IF THE WALL CONTROL WAS INSTALLED BY THE HOSP ACCORDING TO ALM'S WIRING GUIDELINES, IT WOULD HAVE BEEN IMPOSSIBLE TO BE SHOCKED WHEN REMOVING THE FUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM SURGICAL LIGHT FTD ALM SA 550021 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization