BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA VOYAGER

    MDR report key: 11840603 · Received May 18, 2021

    Report

    Report Number
    3010949642-2021-00006
    Event Type
    Injury
    Date Received
    May 18, 2021
    Date of Event
    March 29, 2021
    Report Date
    June 10, 2021
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K161567
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, WHO WAS HAVING A LEFT SHOULDER EXAM AND PASSED MR SCREENING, SUSTAINED A 4-5CM DEEP RED BURN WITH BLISTER ON HER ARM. THE BLISTER WAS OPENED BY A DOCTOR AND WOUND TREATMENT WAS PROVIDED TO AID THE HEALING PROCESS. THE PATIENT'S ARMS WERE ON HER CHEST AND GE RECOMMENDED PADS WERE NOT PROVIDED TO PREVENT BORE OR SKIN TO SKIN CONTACT OR LOOPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736481 SIGNA VOYAGER NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other