BEUDAMED
    FDA Adverse Event Death Summary report: N

    DISCOVERY 670

    MDR report key: 17404591 · Received July 27, 2023

    Report

    Report Number
    9613299-2023-00009
    Event Type
    Death
    Date Received
    July 27, 2023
    Date of Event
    June 27, 2023
    Report Date
    September 26, 2023
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K093514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GE HEALTHCARE (GEHC) FIELD SERVICE ENGINEER (FSE) WAS PERFORMING MAINTENANCE ON A NM/CT 670 TABLE. THE FSE WAS SERIOUSLY INJURED AND FELL UNCONSCIOUS WHEN THE TABLE DROPPED AND STRUCK HIM IN THE HEAD. HE DIED DUE TO THESE INJURIES LATER THAT DAY. NM/CT670 TABLE SERVICE INSTRUCTIONS: NM/CT670 TABLE HAS TWO RED SAFETY STOPPERS UNDER THE TABLE. SAFETY STOPPERS ARE PLACED IN A STORED POSITION WHEN THE TABLE IS IN CLINICAL USE. WHEN THE TABLE IS BEING SERVICED, SAFETY STOPPERS MUST BE MOVED TO THEIR MAINTENANCE? POSITION TO PREVENT THE TABLE FROM DROPPING. GEHC SERVICE MANUAL INSTRUCTS FSES TO MOVE THE SAFETY STOPPERS FROM THEIR STORED? POSITION TO THEIR MAINTENANCE? POSITION PRIOR TO CONDUCTING ANY UNDER-TABLE SERVICING. WHEN PLACED IN MAINTENANCE? POSITION, THE SAFETY STOPPERS ARE EFFECTIVE IN PREVENTING THE TABLE FROM DROPPING. IN ADDITION, THE MANUAL INSTRUCTS THAT TABLE SIDE COVERS NEED TO BE REMOVED PRIOR TO SERVICE UNDER THE TABLE, WHICH ALLOWS AND FSE TO PERFORM MAINTENANCE WITHOUT HAVING TO PLACE THEIR HEAD OR UPPER TORSO UNDER THE TABLE. A WARNING LABEL IS ALSO AFFIXED TO THE COMPONENT BEING SERVICED WHICH STATES WARNING. DANGER OF INJURY OR DAMAGE TO EQUIPMENT. THE SCREWS COVERED BY THIS LABEL MAY BE OPENED BY SERVICE PERSONNEL ONLY. ENSURE THAT THE TABLE ELEVATION MECHANISM IS LOCKED BEFORE OPENING THE SCREWS.? FSES ARE TRAINED ON THESE STEPS PRIOR TO SERVICING GEHC NM/CT 670 TABLES.

    Additional Manufacturer Narrative · 0

    UDI NOT REQUIRED. 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. H3 OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 0

    WHILE A FIELD ENGINEER WAS SERVICING THE DEVICE TABLE, THE ENGINEER REMOVED A COMPONENT WHICH CAUSED THE TOP OF THE TABLE TO FALL. IT STRUCK THE ENGINEER ON THE HEAD, AND THEY WERE TAKEN TO THE ER AT THE HOSPITAL WHERE THE ENGINEER WAS PRONOUNCED DEAD. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322645 DISCOVERY 670 SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING NMH950

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death