BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY 530C

    MDR report key: 7940753 · Received October 5, 2018

    Report

    Report Number
    9613299-2018-00001
    Event Type
    Injury
    Date Received
    October 5, 2018
    Date of Event
    September 4, 2018
    Report Date
    December 7, 2018
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K080124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD ENGINEER REPORTED THAT THE PATIENT RIGHT HAND LITTLE FINGER GOT CAUGHT BETWEEN THE PATIENT TABLE CRADLE (MOVING PART) AND THE TABLE BASE, DURING LINEAR MOTION AS PART OF UNLOAD AFTER SUPINE SCAN. PATIENTS FINGER WAS EXAMINED, AND SMALL FRACTURE WAS FOUND. THE UNLOADING PROCESS AFTER SCAN COMPLETION INCLUDES 3 PHASES: (1) OPERATOR INSTRUCTS PATIENT TO LEAVE ARMS ON ARM SUPPORT, (2) AUTOMATIC MOTION: OPERATOR PRESSES <UNLOAD> + <ENABLE> - THIS INITIATES DETECTORS MOTION FULLY OUT & TABLE MOTION DOWN TO A SAFE HEIGHT (76 CM). UPON MOTION COMPLETION A MESSAGE APPEARS: VERIFY THAT PATIENT LIMBS DO NOT PROTRUDE FROM THE TABLE PALLET. USING THE HAND-HELD CONTROLLER (RCU), MOVE THE TABLE FULLY OUT AND THEN DOWN. (3) CONTINUOUS ACTIVATION MOTION: OPERATOR PRESSES <TABLE OUT> + <ENABLE> AND THEN <TABLE DOWN> + <ENABLE> TO MOVE THE TABLE FULLY OUT AND THEN DOWN. TABLE MOTION CONTINUES ONLY AS LONG AS THESE KEYS ARE PRESSED. NO CORRECTIVE ACTIONS NEEDED TO ADDRESS THE PRIMARY ROOT CAUSE SINCE: USER DOCUMENTATION ALREADY PROVIDES ADEQUATE INSTRUCTIONS & WARNINGS FOR SAFE PATIENT REMOVAL. THE DESIGN IS IN FULL COMPLIANCE WITH IEC STANDARDS.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE UNLOAD PORTION OF AN EXAM, THE PATIENT PINCHED THEIR FINGER BETWEEN THE END OF THE TABLE AND THE FRONT OF THE GANTRY; SUSTAINING A FRACTURED RIGHT LITTLE FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781970 DISCOVERY 530C SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING NMH818

    Patients

    Seq Age Sex Outcome Treatment
    1 Other