BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMX

    MDR report key: 24500926 · Received March 3, 2026

    Report

    Report Number
    2126677-2026-00004
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    February 22, 2026
    Report Date
    March 3, 2026
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZL
    PMA / PMN Number
    K210982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE¿S 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 (GEHC) HAS COMPLETED ITS INVESTIGATION INTO THE REPORTED THERMAL EVENT INVOLVING THE POWER CORD. EVALUATION OF THE RETURNED POWER CORD AND PLUG IDENTIFIED A TAPED JOINT AT THE STRAIN RELIEF LOCATION, INDICATING EVIDENCE OF A PRIOR REPAIR. THIS MODIFICATION RESULTED IN EXPOSURE OF INTERNAL WIRE LEADS. THE COMPROMISED INSULATION AND EXPOSED CONDUCTORS ARE CONSIDERED TO HAVE CONTRIBUTED TO THE THERMAL EVENT. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE WAS THE IMPROPER REPAIR OF THE POWER CORD AND INSUFFICIENT SERVICE INSTRUCTIONS REGARDING REPLACEMENT OF THE POWER PLUG. BASED ON THESE FINDINGS, IT WAS CONCLUDED THAT THE EVENT RESULTED FROM THE COMBINATION OF INSUFFICIENT SERVICE INSTRUCTIONS ON HOW TO REPLACE THE POWER PLUG AND THE EVIDENCE OF A PRIOR IMPROPER REPAIR. AS A CORRECTION, THE POWER CORD REEL ASSEMBLY WAS REPLACED, RESTORING THE SYSTEM TO PROPER OPERATING CONDITIONS. ALSO, THE GEHC FIELD ENGINEERS INVOLVED IN PRIOR SERVICING EVENTS AT THIS SITE WERE REMINDED TO NEVER USE TAPE WHEN REPAIRING A CORD REEL. THESE ACTIONS ADDRESS BOTH RESTORATION OF THE DEVICE AND REINFORCEMENT OF SERVICING EXPECTATIONS TO REDUCE THE LIKELIHOOD OF RECURRENCE.

    Description of Event or Problem · 0

    ON (B)(6) 2026, THE USER FACILITY (B)(6) HOSPITAL (B)(6) REPORTED THAT A FIRE OCCURRED AT THE DEVICE¿S CHARGE PLUG WHILE THE AMX NAVIGATE MOBILE X-RAY SYSTEM WAS CONNECTED TO AN AC POWER OUTLET. ACCORDING TO THE FACILITY, HOSPITAL FIRE DEPARTMENT PERSONNEL WHO WERE ALREADY PRESENT IN THE BUILDING ALSO OBSERVED FLAMES ORIGINATING FROM THE AC PLUG. A FIRE DEPARTMENT MEMBER DONNED FIRE-RESISTANT GLOVES AND DISCONNECTED THE AC PLUG FROM THE WALL OUTLET. NO INJURIES OR DEATHS WERE REPORTED BY THE FACILITY. THE DEVICE WAS REMOVED FROM CLINICAL USE FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142920 AMX SYSTEM, X-RAY, MOBILE IZL GE MEDICAL SYSTEMS, LLC NAVIGATE

    Patients

    Seq Age Sex Outcome Treatment
    1