BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEFINIUM 8000

    MDR report key: 2992703 · Received March 1, 2013

    Report

    Report Number
    2126677-2013-00006
    Event Type
    Other
    Date Received
    March 1, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    GE MEDICAL SYSTEM, LLC
    Product Code
    IZF
    PMA / PMN Number
    K051967
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    "IT WAS REPORTED A THIRD PARTY SERVICE ENGINEER SUSTAINED MINOR INJURIES WHILE SERVICING A DEFINIUM 8000 SYSTEM. THE SERVICE ENGINEER FELT A SHOCK ON HIS HAND AND FELL BACKWARDS, SUSTAINING MINOR BRUISES. THERE WAS NO OTHER INJURY REPORTED AN THE EVENT DID NOT LEAD TO A SERIOUS INJURY. THE IN HOUSE SERVICE PERSONNEL WAS REPLACING THE COLUMN CABLE ASSEMBLY ON THE OVERHEAD TUBE SUPPORT. AS PART OF THE REPAIR, THE INDIVIDUAL INCORRECTLY CONNECTED THE ANODE CABLE TO THE ANODE ON THE TUBE. THE INDIVIDUAL PULLED THE ANODE CABLE FROM THE TUBE AND DISCHARGED THE STORED CAPACITATIVE ENERGY TO HIMSELF AND FELL FROM A LADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89441 DEFINIUM 8000 STATIONARY X-RAY SYSTEM IZF GE MEDICAL SYSTEM, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1