BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DICOM BOX (AAM CA)

    MDR report key: 1184592 · Received September 29, 2008

    Report

    Report Number
    2938727-2008-00001
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Report Date
    September 22, 2008
    Manufacturer
    NAI TECH PRODUCTS, INC.
    Product Code
    LMA
    PMA / PMN Number
    K954875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN REGARDS TO REMEDIAL ACTION, WE ARE SENDING OUT A NOTICE AND REPLACEMENT POWER CORD TO SIMILAR INSTALLATIONS DONE BY NAI TECH PRODUCTS PERSONNEL. WE WILL THEN SEND A TECHNICIAN TO EACH SUCH INSTALLATION AND INSPECT THE WIRING TO ENSURE ALL DEVICES ARE WIRED CORRECTLY.

    Description of Event or Problem · 1

    A DISTRIBUTOR FIELD SERVICE ENGINEER REPORTED THAT SPARKS WERE GENERATED WHEN HE MOVED THE POWER CORD OF THE DEVICE. A REVIEW ONSITE BY NAI TECH PRODUCTS PERSONNEL REVEALED THAT THE POWER CORD OF THE DEVICE HAD BEEN IMPROPERLY WIRED INTO THE INTERNAL POWER SUPPLY TERMINAL BLOCK OF THE C-ARM. THE IMPROPER GROUNDING OF THE DEVICE PRESENTED A POTENTIAL ELECTRICAL SHOCK HAZARD. THE DEVICE HAD BEEN SOLD AS AN ACCESSORY TO THE C-ARM AS AN AFTER SALE PRODUCT. THE DEVICE WAS INSTALLED BY NAI TECH PRODUCTS PERSONNEL IN EARLY 2008 AND FUNCTIONED PROPERLY FOR EIGHT MONTHS WITHOUT ANY INCIDENT DESPITE THIS ELECTRICAL CONDITION. OPERATION OF THE DEVICE IS THROUGH A LOW VOLTAGE HAND CONTROLLER WHICH LIMITED ANY DIRECT CONTACT TO THE DEVICE. PLEASE NOTE THAT THERE WAS NO DEFECT IN THE ACTUAL DEVICE, IT WAS AN INSTALLATION WIRING ERROR BY OUR SERVICE TECHNICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DICOM BOX (AAM CA) DIGITIZER, IMAGE, RADIOLOGICAL (LMA) LMA NAI TECH PRODUCTS, INC. AAM CA

    Patients

    Seq Age Sex Outcome Treatment
    1