BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA PET/MR

    MDR report key: 12563091 · Received October 1, 2021

    Report

    Report Number
    2183553-2021-00010
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    September 3, 2021
    Report Date
    December 8, 2021
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    OUO
    PMA / PMN Number
    K163619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE INVESTIGATION BY GE HEALTHCARE (GEHC) HAS BEEN COMPLETED. BASED ON THE INFORMATION PROVIDED, THE INCIDENT OCCURRED DUE TO A FAILURE TO FOLLOW SERVICE PROCEDURES BY THE GE FIELD ENGINEER (FE). THE FE DID NOT FOLLOW THE PROPER STET TOOL PROCEDURE WHICH SPECIFICALLY INSTRUCTS THE USER THAT THE TOOL IS INTENDED FOR SINGLE PERSON OPERATION ONLY. THE FE HAS BEEN REINSTRUCTED ON THE PROPER OPERATION OF THE STET TOOL.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: TOMOGRAPHIC IMAGER COMBINING EMISSION COMPUTED TOMOGRAPHY WITH NUCLEAR MAGNETIC RESONANCE UNIQUE IDENTIFIER: (B)(4). THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSTALLATION OF A PET/MR SYSTEM, TWO FIELD ENGINEERS (FE) WERE PLACING SHIM TRAYS INTO THE MR SYSTEM. WHILE THEY WERE IN THE PROCESS OF PUSHING A SHIM TRAY INWARD USING A SPECIALIZED GE HEALTHCARE SERVICE TOOL, ONE OF THE FE'S GLOVES HAD BECOME CAUGHT AND HIS FINGER PINCHED. THE PINCH RESULTED IN A LACERATION OF HIS LEFT INDEX FINGER WHICH REQUIRED SEVEN SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457518 SIGNA PET/MR TOMOGRAPHIC IMAGER COMBINING OUO GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other