BEUDAMED
    FDA Adverse Event Other Summary report: N

    CERRETOM NL3000

    MDR report key: 3894245 · Received June 18, 2014

    Report

    Report Number
    3004938766-2014-00005
    Event Type
    Other
    Date Received
    June 18, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 12, 2014
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    JAK
    PMA / PMN Number
    K051765
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS NOT DUPLICATED IN THE REPEATED ATTEMPTS BY THE FACILITY'S RADIOLOGY ENGINEER. NO FURTHER PROBLEMS WERE EXPERIENCED AFTER AN HOUR OF REPEAT TESTING BY SAID PERSONNEL. NEUROLOGICA SENT THE RESPECTIVE FIELD SERVICE ENGINEER TO INVESTIGATE THE SITUATION AT THE FACILITY AND HE WAS NOT SUCCESSFUL IN DUPLICATING THE PROBLEM AFTER MULTIPLE ATTEMPTS. THE SYSTEM AND SDS WERE PHYSICALLY EXERTED DURING THESE ATTEMPTS IN AN EFFORT TO HELP DUPLICATE THE INCIDENT, BUT THE FAILURE DID NOT RECUR. THIS EFFORT WAS WITNESSED BY THE FACILITY STAFF AS WELL. CLINICAL TRAINING WAS SUCCESSFULLY PERFORMED TO ALL NOTED STAFF INVOLVED WITH THIS INCIDENT. THE REPORTED PROBLEM COULD NOT BE DUPLICATED, AND WILL THEREFORE BE MONITORED.

    Description of Event or Problem · 1

    CT TECHNOLOGIST INJURED HER BACK WHILE DRIVING THE SCANNER AND ITS SCANNER DRIVE SYSTEM (SDS, S/N (B)(4)) UP AN INCLINE (APPROXIMATELY 5 DEGREES). THE SDS DECOMPRESSED AND ITS DRIVE WHEELS RETRACTED. AS A RESULT THE ACCOMPANYING SCANNER ANS SAID SDS BEGAN FREELY ROLLING DOWN THE INCLINE, THE CT TECH WENT CHASING AFTER IT, AND (AS MENTIONED) HURT HERSELF (BACK INJURY) WHEN SHE STOPPED THE SYSTEM FROM ROLLING DOWN THE INCLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358449 CERRETOM NL3000 X-RAY COMPUTED TOMOGRAPY SYSTEM JAK NEUROLOGICA CORPORATION NL3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization