BEUDAMED
    FDA Adverse Event Injury Summary report: N

    830 TANDEM

    MDR report key: 23769969 · Received December 10, 2025

    Report

    Report Number
    9613299-2025-00027
    Event Type
    Injury
    Date Received
    December 10, 2025
    Date of Event
    November 13, 2025
    Report Date
    February 10, 2026
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    UDI-DI
    00840682140829
    PMA / PMN Number
    K111445
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI NUMBER: (B)(4). LEGAL MANUFACTURER: HCS HAIFA FI - 4 HAYOZMA ST. ISRAEL TIRAT HACARMEL HEFA, 30200. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    DURING DETECTOR INSTALLATION, THE FE WAS PUSHING THE DETECTOR CART TOWARD THE GANTRY SWIVEL MECHANISM AND HAD POSITIONED THE DETECTOR APPROXIMATELY 50% OF THE WAY ONTO THE GUIDING RODS WHEN HE ENCOUNTERED SOME RESISTANCE. HE LEFT A 5 CM GAP BETWEEN THE DETECTOR AND THE SWIVEL, REPOSITIONED HIMSELF, AND THEN APPLIED ADDITIONAL FORCE TO THE DETECTOR CART USING HIS LEFT HAND. THIS FORCE CAUSED THE DETECTOR CART TO MOVE RAPIDLY, DURING WHICH THE TIP OF THE FES LEFT INDEX FINGER CAME IN BETWEEN THE MATING PARTS, RESULTING IN A FRACTURE. THE FE SECURED THE DETECTOR IN PLACE AND THEN SOUGHT FIRST AID. LATER THAT DAY, HE RETURNED AND COMPLETED THE INSTALLATION. GE HEALTHCARE'S INVESTIGATION DETERMINED THAT THE ROOT CAUSE WAS INATTENTIVENESS BY THE FE WHILE FOLLOWING THE INSTALLATION PROCEDURE. THE RISK ANALYSIS DETERMINED THAT NO ADDITIONAL MITIGATIONS ARE AVAILABLE TO REDUCE THE RISK, AND THE RISK HAS BEEN REDUCED AS FAR AS POSSIBLE. NO FURTHER ACTIONS ARE PLANNED BY GE HEALTHCARE.

    Description of Event or Problem · 0

    A GE HEALTHCARE FIELD ENGINEER SUSTAINED A FINGER FRACTURE DURING THE INSTALLATION OF AN 830 TANDEM SYSTEM DETECTOR. THE INJURY OCCURRED WHEN THE ENGINEER LEFT INDEX FINGER BECAME TRAPPED BETWEEN THE GANTRY SWIVEL MECHANISM AND THE DETECTOR WHILE MOVING THE DETECTOR TOWARD THE SWIVEL MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193729 830 TANDEM SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING NMH972 00840682140829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| O