BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNITOM

    MDR report key: 12847856 · Received November 19, 2021

    Report

    Report Number
    3004938766-2021-00015
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 26, 2021
    Report Date
    November 19, 2021
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    JAK
    PMA / PMN Number
    K171183
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY A CUSTOMER THAT A SCANNER WAS DRIVING INCORRECTLY. WHILE DRIVING THE DEVICE, A TECHNICIAN WAS PINNED AGAINST A WALL. THERE WAS NO ADDITIONAL INFORMATION ON USER INJURY PROVIDED. WHILE FURTHER INVESTIGATING, THE FIELD SERVICE ENGINEER DETERMINED THAT THE WHEEL HUBS WERE MALFUNCTIONING, WHICH CONTRIBUTED TO THE DIFFICULTY IN DRIVING THE DEVICE THE USER EXPERIENCED. HOWEVER, IT WAS ALSO CONVEYED THAT THE TECHNICIAN WHO DROVE THE SCANNER WAS NOT ADEQUATELY TRAINED ON DRIVING THE DEVICE. THE DRIVE BAR AND REQUIRED COMPONENTS WERE REPLACED AND THE FIELD SERVICE TECHNICIAN STATED THE DEVICE WAS WORKING APPROPRIATELY AFTER THE REPAIR. TO FURTHER MITIGATE THIS INCIDENT, NEUROLOGICA WILL BE CONDUCTING A TRAINING SEMINAR WITH THE SITE ON HOW TO APPROPRIATELY DRIVE THE DEVICE.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY A CUSTOMER THAT A SCANNER WAS DRIVING INCORRECTLY. WHILE DRIVING THE DEVICE, A TECHNICIAN WAS PINNED AGAINST A WALL. THERE WAS NO ADDITIONAL INFORMATION ON USER INJURY PROVIDED. WHILE FURTHER INVESTIGATING, THE FIELD SERVICE ENGINEER DETERMINED THAT THE WHEEL HUBS WERE MALFUNCTIONING, WHICH CONTRIBUTED TO THE DIFFICULTY IN DRIVING THE DEVICE THE USER EXPERIENCED. HOWEVER, IT WAS ALSO CONVEYED THAT THE TECHNICIAN WHO DROVE THE SCANNER WAS NOT ADEQUATELY TRAINED ON DRIVING THE DEVICE. THE DRIVE BAR AND REQUIRED COMPONENTS WERE REPLACED AND THE FIELD SERVICE TECHNICIAN STATED THE DEVICE WAS WORKING APPROPRIATELY AFTER THE REPAIR. TO FURTHER MITIGATE THIS INCIDENT, NEUROLOGICA WILL BE CONDUCTING A TRAINING SEMINAR WITH THE SITE ON HOW TO APPROPRIATELY DRIVE THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE SCANNER WAS NOT DRIVING CORRECTLY. WHEN PRESSING THE DRIVEBAR TO MOVE THE DEVICE, THE DEVICE WAS SAID TO MOVE BACKWARDS. PER FEEDBACK RECEIVED FROM FIELD SERVICE, A TECHNICIAN WAS PINNED AGAINST THE WALL WHILE ATTEMPTING TO DRIVE THE DEVICE. NO INJURY TO THE OPERATOR WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE SCANNER WAS NOT DRIVING CORRECTLY. WHEN PRESSING THE DRIVEBAR TO MOVE THE DEVICE, THE DEVICE WAS SAID TO MOVE BACKWARDS. PER FEEDBACK RECEIVED FROM FIELD SERVICE, A TECHNICIAN WAS PINNED AGAINST THE WALL WHILE ATTEMPTING TO DRIVE THE DEVICE. NO INJURY TO THE OPERATOR WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742569 OMNITOM COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK NEUROLOGICA CORPORATION NL5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown