BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T SIGNA HDX ECHOSPEED

    MDR report key: 2023337 · Received March 16, 2011

    Report

    Report Number
    2183553-2011-00010
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    March 16, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A GEHC LOCAL FIELD TEAM WAS DISPATCHED TO THE CUSTOMER SITE TO OBTAIN SCAN SPECIFIC INFO AND INVESTIGATE THE ENVIRONMENTAL CONDITIONS. THE INVESTIGATION FOCUSED ON FOUR MAIN AREAS: ENVIRONMENTAL: (INCLUDING COOLING EQUIPMENT, PT AIR COOLING PLUS THE MR SCANNER ERROR LOG). SURFACE COILS/ACCESSORIES: (SURFACE COIL/ECG CHECKS). SYSTEM/IMAGE QUALITY: (SYSTEM LEVEL TESTING TO CHECK FOR SYSTEM FAILURES). PT MONITORING: (PT ALARM & RF SAFETY MONITOR CHECKS). VISUAL INSPECTION AND THE TEST RESULTS FOR THE MRI SYSTEM SHOW NO ISSUES THAT CAUSED OR CONTRIBUTED TO THE BURN. THE SYSTEM WAS DETERMINED TO BE FUNCTIONING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANESTHETIZED PT RECEIVED A BLISTER ON HER LEFT ELBOW AFTER AN MR PELVIC SCAN WITH THE BODY ARRAY COIL. THE SIZE OF THE BLISTER IS BETWEEN 6 TO 7 CM. THE PT RECEIVED A BANDAGE OVER THE ELBOW. NO FURTHER DETAILS WERE PROVIDED REGARDING THE MEDICAL TREATMENT OF THIS PT. THE PT WAS POSITIONED FEET FIRST WITH HER ARMS ABOVE HER HEAD. THE PT WARMING QUESTIONNAIRE INDICATES THAT PADDING WAS NOT USED TO PAD THE PT AWAY FROM THE BORE, AND THAT THE SITE USED A BED SHEET IN LIEU OF PADDING. THE PULSE SEQUENCES USED WERE FSE, FGR, FRFSE-XL, FSE-XL AND LAVA. THE PT WAS SCANNED FOR TWELVE SERIES. THE DURATION FOR THE SERIES WAS AS FOLLOWS: FSE - 26 SEC, FSE - 26 SEC, FGR - 13 SEC, FRFSE-XL - 3 MINS 45 SEC, FRFSE-XL - 3 MINS 51 SEC, FSE - 26 SEC, FRFSE-XL - 3 MINS 7 SEC, FSE-XL - 3 MINS 53 SEC, FSE-XL - 2 MINS 49 SEC, FSE-XL - 3 MINS 49 SEC, LAVA - 15 SEC, AND FSE - XL - 3 MINS 53 SEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5T SIGNA HDX ECHOSPEED MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC 2138300-19

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other