BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0T SIGNA HDXT

    MDR report key: 5057118 · Received September 4, 2015

    Report

    Report Number
    2183553-2015-00021
    Event Type
    Injury
    Date Received
    September 4, 2015
    Date of Event
    August 4, 2015
    Report Date
    August 5, 2015
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K121676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). GE HEALTHCARE'S INVESTIGATION INDICATES THAT THE INCIDENT APPEARS TO BE THE RESULT OF THE FAILURE TO ADEQUATELY SCREEN THE PATIENT FOR NON-MR COMPATIBLE MATERIALS, RESULTING IN SUPERFICIAL CONTACT WITH CONDUCTIVE MATERIAL THAT WAS SUSCEPTIBLE TO HIGH POWER RADIO-FREQUENCY (RF) TRANSMISSION, RESULTING IN A BURN. THE CONDUCTIVE MATERIAL WAS A METAL RING USED TO MONITOR THE PATIENT'S PULSE AND BLOOD PRESSURE, AND WAS LEFT ON THE LEFT THUMB. ADDITIONALLY, THE PATIENT WAS SEDATED DURING THE SCAN, AND MAY NOT HAVE BEEN ABLE TO ALERT THE OPERATOR OF ANY WARMING SENSATIONS THEY MAY HAVE EXPERIENCED DURING THE SCAN. ALL REVIEWED DATA INDICATE THE RF RELATED SAFETY MITIGATIONS (RF AMPLIFIER OUTPUT AND REDUNDANT POWER MONITORS) WERE FUNCTIONING NORMALLY AT THE TIME. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION REGARDING PATIENT SCREENING, MONITORING, SCAN PREPARATION, SCAN INFORMATION, OR LEVEL OF TECHNOLOGIST TRAINING THAT MAY HAVE AFFECTED THIS INCIDENT. THE AVAILABLE INFORMATION DID NOT INDICATE THERE WERE ANY SYSTEM RELATED ISSUES THAT MAY HAVE CONTRIBUTED TO THE INCIDENT. THERE IS NO EVIDENCE THAT THE MR SYSTEM MALFUNCTIONED. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT AN MRI OF THE PANCREAS AND RECEIVED A BURN TO THE LEFT THUMB. THE PATIENT'S MOTHER STATED THAT THE MEDICAL STAFF FORGOT TO REMOVE FROM THE PATIENT'S FINGER A METAL SENSOR BEFORE USING THE MAGNETIC SCANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589092 3.0T SIGNA HDXT NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE MEDICAL SYSTEMS, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other