BEUDAMED
    FDA Adverse Event Other Summary report: N

    CERETOM NL3000

    MDR report key: 3649069 · Received February 14, 2014

    Report

    Report Number
    3004938766-2014-00004
    Event Type
    Other
    Date Received
    February 14, 2014
    Date of Event
    March 3, 2013
    Report Date
    February 14, 2014
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    JAK
    PMA / PMN Number
    K051765
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    APPARENTLY ONE TECHNICIAN TRIED TO MOVE THE SCANNER WHEN ALIGNING THE PATIENT IN PREPARATION FOR SCAN. PER OUR USER MANUAL FOR THE CERETOM (1-NL3000-060), IT IS RECOMMENDED THAT TWO PEOPLE MOVE THE SCANNER WHEN THE SCANNER DRIVE SYSTEM IS NOT CONNECTED - THIS IS OUTLINED IN AT LEAST TWO LOCATIONS WITHIN SAID DOCUMENT. ADDITIONALLY, THIS POINT IS FURTHER EMPHASIZED DURING THE MANDATORY CLINICAL TRAINING THAT IS PROVIDED BY NEUROLOGICA'S CLINICAL TRAINING STAFF. THIS ADVERSE EVENT WAS NOT FORMALLY REPORTED TO NEUROLOGICA CORP. BY THE USER FACILITY UNTIL JANUARY, 2014.

    Description of Event or Problem · 1

    AN OPERATOR AT THE FACILITY SUSTAINED A BACK INJURY TO HIS/HER BACK WHILE POSITIONING THE SYSTEM ON THEIR OWN (WITHOUT THE USE OF A SUPPORTING DRIVE SYSTEM) IN PREPARATION OF PERFORMING A PRESCRIBED SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97790 CERETOM NL3000 X-RAY COMPUTED TOMOGRAPHY SYSTEM JAK NEUROLOGICA CORPORATION NL3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA