BEUDAMED
    FDA Adverse Event Summary report: N

    PMX-2000

    MDR report key: 92359 · Received May 14, 1997

    Report

    Report Number
    1220984-1997-00009
    Date Received
    May 14, 1997
    Date of Event
    April 9, 1997
    Report Date
    May 13, 1997
    Manufacturer
    LORAD
    Product Code
    IZL
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, THE X-RAY TECHNICIAN INJURED HER ARM WHILE POSITIONING THE X-RAY TUBE ON THE PMX-2000 UNIT. REPORTEDLY, THE X-RAY TECHNICIAN IS NOT WORKING DUE TO THE INJURY AND IS OUT ON DISABILITY. REPORTEDLY, PRELIMINARY FINDINGS FOUND THAT THE SOLENOID BRAKE INSIDE THE X-RAY TUBE COLUMN WAS ACTIVATING INTERMITTENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PMX-2000 RADIOGRAPHIC IZL LORAD 9804-086-00009 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other