BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 2100-IQ

    MDR report key: 2841942 · Received November 14, 2012

    Report

    Report Number
    9611343-2012-00042
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    MQB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THE MANUFACTURING DATE IS UNKNOWN AT THIS TIME HENCE IDENTIFICATION OF THE 510 (K) NUMBER TO BE INCLUDED WHICH DIRECTLY SUPPORTS THIS DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    WHEN A GE HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS INSTALLING AN INNOVA 2100-IQ, THE SYSTEM COULD NOT BE TURNED ON. THE FSE WAS TROUBLESHOOTING THE SYSTEM AND REACHED INSIDE CABINET 2 HOLDING THE TEST PROBE OF THE MULTI-METER IN HIS RIGHT HAND IN ORDER TO GET ACCESS TO THE CONNECTOR BETWEEN THE MAIN FILTER PANEL AND THE POWER DISTRIBUTION UNIT (PDU) CABLES. WHEN HE REACHED THE CONNECTOR HE RECEIVED AN ELECTRICAL SHOCK DUE TO A LOOSE CABLE PIN ON THE CONNECTOR. HE COULD FREE HIMSELF FROM THE CABLE BUT RECEIVED A SECOND DEGREE BURN ON HIS RIGHT THUMB. HE WAS ADMITTED TO THE HOSPITAL FOR SURVEILLANCE OVERNIGHT AND RELEASED THE NEXT MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2100-IQ FLUOROSCOPIC X-RAY SYSTEM MQB GE MEDICAL SYSTEMS 12591K

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization