BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPOT FILM DEVICE

    MDR report key: 451214 · Received March 26, 2003

    Report

    Report Number
    2126677-2003-00005
    Event Type
    Malfunction
    Date Received
    March 26, 2003
    Date of Event
    February 25, 2003
    Report Date
    March 25, 2003
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    JAA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE VIDEO CAMERA FELL OFF THE SPOT FILM DEVICE (SFD) AND LANDED ON THE ARM OF A PERSON. THE FOUR SCREWS ATTACHING THE CAMERA TO THE SFD APPARENTLY CAME LOOSE OVER TIME, UNTIL THEY FAILED TO KEEP THE CAMERA ATTACHED PROPERLY. THE DEVICE WAS REPAIRED AND RETURNED TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPOT FILM DEVICE DIAGNOSTIC X-RAY JAA GE MEDICAL SYSTEMS 2118104 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other