BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIMA XR240AMX

    MDR report key: 9235992 · Received October 24, 2019

    Report

    Report Number
    2126677-2019-00013
    Event Type
    Death
    Date Received
    October 24, 2019
    Date of Event
    September 4, 2019
    Report Date
    January 20, 2020
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZL
    PMA / PMN Number
    K162990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE HAS INITIATED A ROOT CAUSE INVESTIGATION WHICH IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS COMPLETED. PATIENT IDENTIFIER: PATIENT IDENTIFIER WAS NOT PROVIDED. UDI# (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    GE "HEALTHCARE¿¿S" INVESTIGATION HAS BEEN COMPLETED AND THE ROOT CAUSE WAS DETERMINED TO BE DUE TO USE ERROR. IF THE DETECTOR IS PLACED INCORRECTLY BEHIND THE PATIENT, THE SYSTEM ALLOWS THE USER TO ROTATE, FLIP AND USE THE PATIENT ORIENTATION FUNCTIONS TO CORRECT THE ORIENTATION. FOR THIS CASE, THE OPERATOR ATTEMPTED TO CORRECT THE IMAGE THROUGH ROTATION OF THE IMAGE 180 DEGREES BUT ALSO UNINTENTIONALLY FLIPPED (HORIZONTAL FLIP) THE IMAGE. THE OPERATOR ALSO DID NOT USE EXTERNAL LEAD MARKERS OR CHOOSE TO USE THE ELECTRONIC MARKERS DURING THIS PATIENT EXAM. THE IMAGE WAS THEN MISDIAGNOSED AS A RIGHT SIDED PNEUMOTHORAX AND A CHEST TUBE WAS INSERTED IN THE INCORRECT LUNG. THERE WERE NO PROBLEMS IDENTIFIED WITH THE OPTIMA XR240AMX SYSTEM. RECOMMENDATIONS WERE MADE TO THE USER TO ALWAYS TO PLACE THE DETECTOR IN THE INTENDED DIRECTION OF THE PATIENT POSITION TO AVOID ANY CORRECTIONS POST EXPOSURE AND TO USE THE ELECTRONIC LEFT/RIGHT MARKER FUNCTIONALITY. NO FURTHER ACTIONS ARE NEEDED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE CUSTOMER AT (B)(6) MEDICAL CENTER REPORTED THAT WHEN THEY WERE PERFORMING A STAT CHEST X-RAY USING THEIR OPTIMA XR240AMX MOBILE RADIOGRAPHIC SYSTEM ON A NICU PATIENT ON (B)(6) 2019, THE TECHNOLOGIST COMPLETED THE EXAM WITH THE DETECTOR PLACED UPSIDE DOWN UNDER THE PATIENT. UPON COMPLETION OF THE EXPOSURE AND DURING REPROCESSING OF THE IMAGE, THE TECHNOLOGIST ATTEMPTED TO CORRECT THE IMAGE ORIENTATION BY ROTATING THE IMAGE 180 DEGREES BUT FIRST INADVERTENTLY FLIPPED THE IMAGE WITHOUT REALIZING IT. THE TECHNOLOGIST THEN PROCEEDED TO ROTATE THE IMAGE 180 DEGREE WHICH RESULTED IN AN IMAGE ORIENTATION SHOWING AN AP SUPINE CHEST, YET RIGHT AND LEFT ORIENTATION WAS REVERSED. DUE TO THE NEED FOR STERILITY DURING THE PROCEDURE, ROUTINE LEAD MARKERS COULD NOT BE USED. THE PATIENT HAD A RIGHT SIDED PNEUMOTHORAX, BUT THE RADIOLOGIST MISDIAGNOSED AS A LEFT SIDE PNEUMOTHORAX AND A CHEST TUBE WAS INSERTED IN THE INCORRECT LUNG. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030571 OPTIMA XR240AMX SYSTEM, X-RAY, MOBILE IZL GE MEDICAL SYSTEMS, LLC 5555000

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Death