BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNITOM

    MDR report key: 11043001 · Received December 19, 2020

    Report

    Report Number
    3004938766-2020-00014
    Event Type
    Malfunction
    Date Received
    December 19, 2020
    Date of Event
    November 20, 2020
    Report Date
    December 18, 2020
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    JAK
    PMA / PMN Number
    K171183
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER REPLACED THE DRIVE BAR AND COMPONENTS. CALIBRATION AND QA WAS COMPLETED. FIELD SERVICE ENGINEER TEST DROVE THE SCANNER, AND SUCCESSFULLY COMPLETED DAILY CALIBRATION. NO PATIENT HARM OR OTHER ISSUES REPORTED.

    Description of Event or Problem · 1

    CALLER REPORTED THE SCANNER PINNED OPERATOR WHEN TRYING TO MANEUVER THE DEVICE AND BROKE THE DRIVE BAR. NO REPORTED INJURY TO THE OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507447 OMNITOM COMPUTED TOMOGRAPHY X-RAY SYSTEM, JAK NEUROLOGICA CORPORATION NL5000

    Patients

    Seq Age Sex Outcome Treatment
    1