BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA EXPLORER

    MDR report key: 11609410 · Received April 2, 2021

    Report

    Report Number
    3010949642-2021-00002
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    December 28, 2020
    Report Date
    May 4, 2021
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K143251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE INVESTIGATION BY GE HEALTHCARE (GEHC) HAS BEEN COMPLETED. THE MR SYSTEM WAS OPERATING WITHIN SPECIFICATIONS AND ALL SAFETY MITIGATING DEVICES WERE FUNCTIONAL WHEN CHECKED BY THE GEHC FIELD ENGINEER. THE ROOT CAUSE OF THE INJURY WAS DETERMINED TO BE INADEQUATE PATIENT PADDING FOR THE MRI PROCEDURE. THE OPERATOR DOCUMENTATION DESCRIBES THE APPROPRIATE SAFETY MEASURES FOR PADDING PATIENTS FOR MR EXAMS. THE MR OPERATOR HAS THE FINAL RESPONSIBILITY FOR THE USE AND PLACEMENT OF NON-CONDUCTIVE MR COMPATIBLE PADDING AND PREPARATION OF THE PATIENT, PRIOR TO STARTING THE MR EXAM PROCEDURE. NO FURTHER ACTIONS ARE PLANNED BY GEHC.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN MR EXAMINATION, A PATIENT DEVELOPED A SUPERFICIAL BURN AROUND THE NAVEL. AT THE TIME OF THE SCAN, THERE WAS NO REDNESS, HOWEVER WHEN THE PATIENT COMPLAINED OF THE BURNING, THE TECH MOVED THE PATIENT'S CLASPED HANDS AWAY FROM THEIR ABDOMEN. THE CUSTOMER INDICATED THAT SOME PADDING WAS USED, HOWEVER NO PADDING WAS USED TO PREVENT THE HANDS FROM CLASPING EACH OTHER OR THE CLASPED HANDS FROM RESTING DIRECTLY ON THE PATIENT'S ABDOMEN. THE PATIENT DID NOT REQUIRE ANY MEDICAL ATTENTION FOR THE INITIAL BURN. IT WAS LATER REPORTED THAT THE PATIENT, WHO PASSED THE MR SCREENING AND WAS WEARING MR COMPATIBLE CLOTHING, SUSTAINED A 20X10CM PARTIAL THICKNESS BURN AND A 5X5CM FULL THICKNESS BURN ON HER ABDOMEN THAT REQUIRED SURGICAL EXCISION OF THE NECROTIC TISSUE TO HEAL. PLASTIC SURGERY WAS COMPLETED ON DAY SIX POST SCAN. AT THE TIME, THERE WERE EARLY SIGNS OF INFECTION TO THE BURN WOUND AND THE PATIENT WAS HOSPITALIZED FOR A WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506502 SIGNA EXPLORER NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| O