BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMX 4

    MDR report key: 294319 · Received September 1, 2000

    Report

    Report Number
    2126677-2000-00010
    Event Type
    Injury
    Date Received
    September 1, 2000
    Date of Event
    July 28, 2000
    Report Date
    August 31, 2000
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    IZL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GEMS THAT A TECHNICIAN INJURED TECHNICIAN'S BACK WHILE USING AN AMX 4. THE TECHNICIAN WAS UNAWARE THAT THE UNIT WAS NOT FULLY FUNCTIONAL. TECHNICIAN WAS MOVING THE UNIT AND WHEN THE UNIT STOPPED, IT JERKED AND TECHNICIAN LUNGED INTO IT. THE TECHNICIAN WAS PRESCRIBED THERAPY AND PLACED ON DISABILITY. THE "FE" WAS SERVICING THE EQUIPMENT AND WAS WAITING FOR A NEW PART BUT DID NOT REMOVE THE UNIT FROM OPERATION AT THAT TIME. THERE WAS NO INDICATION ON THE UNIT IDENTIFYING THAT THE UNIT WAS NOT FULLY FUNCTIONAL. THE SYSTEM HAS NOW BEEN REPAIRED AND RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMX 4 DIAGNOSTIC X-RAY IZL GE MEDICAL SYSTEMS 2115090-13 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other