BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRILLANCE ICT

    MDR report key: 1648293 · Received March 29, 2010

    Report

    Report Number
    1525965-2010-00004
    Event Type
    Injury
    Date Received
    March 29, 2010
    Report Date
    March 4, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K060937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVENT OCCURRED ON (B) (6) 2010. (B) (4).

    Description of Event or Problem · 1

    A FIELD SERVICE ENGINEER WAS CLOSING THE GANTRY COVER WHEN AN ELECTRICAL SHOCK WAS RECEIVED WHEN THE COVER LATCH CAME INTO CONTACT WITH THE CABLING. NOTE: THE SYSTEM INVOLVED IN THIS EVENT IS IN OUR TRAINING CENTER FOR FIELD SERVICE ENGINEER TRAINING, AND THUS IS SUBJECTED TO A MUCH HIGHER USE RATE THAN TYPICAL SYSTEMS INSTALLED IN THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLANCE ICT JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728311

    Patients

    Seq Age Sex Outcome Treatment
    1