BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMX MOBILE X-RAY SYSTEM

    MDR report key: 2460842 · Received February 13, 2012

    Report

    Report Number
    2126677-2012-00020
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    June 23, 2012
    Report Date
    June 24, 2012
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZL
    PMA / PMN Number
    K910902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THIS EVENT WAS ORIGINALLY REPORTED ON 07/21/2011 UNDER MDR 9611343-2011-00056. THE MFG SITE LOCATION IS BEING CORRECTED FROM GE MEDICAL (B)(4), TO GE MEDICAL SYSTEMS, LLC (B)(4). THIS REPORT (MDR 2126677-2012-00020) REPLACES MDR 9611343-2011-00056. GE HEALTHCARE INVESTIGATED THE REPORTED EVENT. ON SITE EVAL REVEALED THAT THE COVER (CURTAIN KIT) OF THE X-RAY MACHINE WAS BROKEN. IN ADDITION, THE OUTER COVERING OF TWO CABLES (ANODE ROTATION CABLE AND COLLIMATOR CABLE) WAS DAMAGED, EXPOSING COPPER WIRES. THE REPORTED INJURY OCCURRED WHEN THE OPERATOR PLACED THEIR HAND INSIDE THE ARM, TOUCHING THE EXPOSED WIRES WHILE EITHER ENERGIZING THE FIELD LIGHT OR WHILE IN PREP. IT IS UNK WHICH CABLE THE OPERATOR CAME IN CONTACT WITH. THE ANODE ROTATION CABLE CARRIES 120VAC FOR THE FIRST 2.5 SECONDS OF PREP, AND THEN 60VAC FOR THE REMAINDER OF PREP. THE COLLIMATOR CABLE CARRIES 24VAC TO THE FIELD LIGHT ONLY WHEN IT IS COMMANDED ON. THE LIKELY ELECTRICAL SOURCE TOUCHED IS 24VAC, WHICH WOULD BE ACTIVE DURING POSITIONING WITH THE FIELD LIGHT ON. A SITE CORRECTION WAS COMPLETED ON (B)(4) 2011. THE CURTAIN KIT, ANODE ROTATION CABLE, AND COLLIMATOR CABLE WERE REPLACED. NO FURTHER INCIDENCE HAS BEEN REPORTED. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME. THE CURTAIN KIT PROVIDES PROTECTION FOR THE OPERATOR FROM THIS ELECTRICAL ENERGY BY PREVENTING CONTACT. IN THIS INSTANCE, THE COVER WAS BROKEN, NOT REPAIRED OR REPLACED, AND THE MACHINE CONTINUED TO BE USED. AFTER THE COVER WAS BROKEN, SEVERAL WIRES INSIDE THE ARM BECAME SKINNED, LIKELY DO TO WEAR-OUT, EXPOSING THE WIRES WITHIN. IT SHOULD BE NOTED THAT, IN THE SERVICE MANUAL FOR THIS PRODUCT, THERE IS AN ANNUAL VISUAL INSPECTION OF THE CABLES ALONG THE ARM. THIS INSPECTION IS REPEATED IN THE OPERATOR MANUAL IN SECTION 1-15. THE ANNUAL PREVENTIVE MAINTENANCE OUTLINED IN THE SERVICE MANUAL SHOULD IDENTIFY DAMAGED WIRES IN THE ARM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE POSITIONING THE VMX MOBILE X-RAY SYSTEM, THE OPERATOR WAS SHOCKED WHEN HE CAME INTO CONTACT WITH A MALFUNCTIONING HIGH VOLTAGE CABLE. HE SUSTAINED A MUSCULAR PROBLEM DUE TO A SUDDEN MOVEMENT OF THE ARM AFTER THE SHOCK. SUBSEQUENT F/U WITH THE SITE CONFIRMED THAT MEDICAL INTERVENTION WAS NOT REQUIRED AND A SERIOUS INJURY DID NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VMX MOBILE X-RAY SYSTEM MOBILE X-RAY SYSTEM IZL GE MEDICAL SYSTEMS, LLC 45296966

    Patients

    Seq Age Sex Outcome Treatment
    1