BEUDAMED
    FDA Adverse Event Other Summary report: N

    APX 525 X-RAY GENERATOR

    MDR report key: 1966528 · Received January 14, 2011

    Report

    Report Number
    1418964-2011-00001
    Event Type
    Other
    Date Received
    January 14, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    DEL MEDICAL INC.
    Product Code
    IZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE ENGINEER WAS IN THE PROCESS OF REPLACING SOME OLD PRINTED CIRCUIT BOARDS WHEN A FUSE BLEW. HE FAILED TO FULLY DISCHARGE THE CAPACITORS BEFORE WORKING ON INTERNAL CIRCUITRY AS EXPLAINED IN THE MANUAL AND THE RESULTING SHOCK CAUSED THE REPORTED INJURY. THIS INJURY WAS NOT A RESULT OF A DEVICE MALFUNCTION BUT A FAILURE OF THE SERVICE ENGINEER TO OBSERVE PROPER ELECTRICAL SAFETY TECHNIQUES AND WARNINGS. CONCLUSION: SERVICE ERROR CAUSED THE EVENT. IN OUR REVIEW OF THIS EVENT THERE WAS SOME UNCERTAINTY AS TO WHETHER THE REPORTED INJURY FIT THE FDA DEFINITION OF SERIOUS INJURY. WE TAKE ALL INJURIES SERIOUSLY AND FELT IT WAS BETTER TO REPORT THIS EVENT THAN NOT.

    Description of Event or Problem · 1

    THE EVENT HAPPENED TO A SERVICE ENGINEER NOT A PATIENT. WITH THE X-RAY GENERATOR TURNED OFF, THE SERVICE ENGINEER WAS REMOVING DEBRIS FROM A BLOWN INVERTER FUSE AND RECEIVED AN ELECTRICAL SHOCK AS HE MADE CONTACT WITH THE DC RAIL WITH HIS HAND. THE REFLEX FROM THE SHOCK CAUSED HIS HAND TO PULL BACK AND MAKE CONTACT WITH A SHARP OBJECT WITHIN THE GENERATOR HOUSING CUTTING HIS HAND. HE WENT TO THE HOSPITAL, WAS TREATED FOR THE CUT ON HIS HAND AND RELEASED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APX 525 X-RAY GENERATOR IZO DEL MEDICAL INC. 110-0128G2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention