BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMX

    MDR report key: 23973829 · Received January 6, 2026

    Report

    Report Number
    2126677-2026-00002
    Event Type
    Injury
    Date Received
    January 6, 2026
    Date of Event
    December 18, 2025
    Report Date
    March 10, 2026
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZL
    PMA / PMN Number
    K210982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE HÂS INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. LEGAL MANUFACTURER: GE MEDICAL SYSTEMS, LLC - 3000 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE CONDUCTED A FULL INVESTIGATION AND CONFIRMED THE CAUSE OF THE THERMAL EVENT. THE INVESTIGATION DETERMINED THAT THE SERVICE PERSONNEL DID NOT COMPLETE THE REQUIRED LOCK OUT/TAG OUT (LOTO) PROCEDURE BEFORE BEGINNING WORK. IN ADDITION, AN ALCOHOL-BASED HAND SANITIZER WAS STORED ON THE UNIT AND NOT REMOVED BY THE SERVICE PERSON, AND A SMALL AMOUNT OF THIS LIQUID CONTACTED ENERGIZED INTERNAL COMPONENTS. CONTACT BETWEEN THE FLAMMABLE LIQUID AND ENERGIZED CIRCUITRY LED TO AN ELECTRICAL SHORT AND SUBSEQUENT IGNITION. THE RESULTING FIRE DAMAGED THE CIRCUIT BOARD, FUSE SHIELD, AND NEARBY WIRING. BECAUSE THE BATTERY LEADS REMAINED CONNECTED, ENERGY CONTINUED TO SUSTAIN COMBUSTION UNTIL THE BATTERY WAS PHYSICALLY DISCONNECTED. ONCE BATTERY POWER WAS ISOLATED, THE FIRE WAS EXTINGUISHED. DUE TO THE EXTENT OF THE DAMAGE, THE AFFECTED SYSTEM WAS REPLACED. GE HEALTHCARE ISSUED A GLOBAL COMMUNICATION TO SERVICE PERSONNEL REINFORCING ENVIRONMENTAL SAFETY PRECAUTIONS DURING SERVICE, INCLUDING ENSURING ALL FLAMMABLE MATERIALS ARE REMOVED FROM THE SERVICE AREA, COMPLETING ALL LOTO STEPS PRIOR TO ACCESSING INTERNAL COMPONENTS AND SECURING THE AREA AND LIMITING ACCESS TO ESSENTIAL PERSONNEL ONLY. BASED ON THE COMPLETED INVESTIGATION AND IMPLEMENTED ACTIONS, NO FURTHER CORRECTIVE MEASURES ARE REQUIRED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A GE HEALTHCARE FIELD ENGINEER (GEHC FE) REPORTED THAT DURING SERVICE ACTIVITIES ON AN AMX NAVIGATE MOBILE X-RAY SYSTEM AT RS KANKER DHARMAIS, INDONESIA, A FIRE OCCURRED WHILE THE SYSTEMÂS PROTECTIVE COVERS WERE REMOVED. THE THERMAL EVENT LASTED APPROXIMATELY 40 MINUTES, PRODUCING A SIGNIFICANT AMOUNT OF SMOKE. THE FIRE WAS EXTINGUISHED BY DISCONNECTING THE BATTERY CABLING. THREE INDIVIDUALS (ONE GEHC FE, ONE HOSPITAL TECHNOLOGIST, AND ONE HOSPITAL HELPER) EXPERIENCED OXYGEN DEPRIVATION. ALL WERE HOSPITALIZED AND TREATED WITH OXYGEN THERAPY AND NEBULIZATION. THIS INCIDENT WAS CLASSIFIED AS A SERIOUS INJURY. THIS REPORT WILL ADDRESS THE HOSPITAL TECHNOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39561 AMX SYSTEM, X-RAY, MOBILE IZL GE MEDICAL SYSTEMS, LLC NAVIGATE

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Required Intervention