BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0T HD MR

    MDR report key: 1637152 · Received March 19, 2010

    Report

    Report Number
    2183553-2010-00005
    Event Type
    Injury
    Date Received
    March 19, 2010
    Date of Event
    February 15, 2010
    Report Date
    March 3, 2010
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K041476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GEHC INVESTIGATION WAS COMPLETED. 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 AND RF SAFETY MONITOR CHECKS). VISUAL INSPECTION AND THE TEST RESULTS FOR THE SYSTEM SHOWED 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 A PT RETURNED TO THE HOSPITAL SEVERAL DAYS AFTER RECEIVING A MR EXAM WITH A 2-INCH SCAB BELOW HIS LEFT KNEE. THE SCAB SUGGESTED THAT THE PT MIGHT HAVE SUSTAINED A 2-INCH BLISTER. THE PT DID NOT RECEIVE ANY TREATMENT. THE EXAM RECEIVED BY THE PT WAS LANDMARKED FOR THE MID-FEMUR LEG WHICH LASTED APPROXIMATELY 20 MINUTES. THE TECHNOLOGIST REPORTEDLY USED PROPER PADDING TO PREVENT SKIN-TO-SKIN CONTACT DURING THE EXAM. THE HOSPITAL TECHNOLOGIST ALSO REPORTED THAT THE PT'S HANDS WERE NOT CLASPED DURING THIS TIME. ADDITIONALLY, THE PT WAS NOT IN CONTACT WITH ANY CONDUCTING MATERIALS DURING THE EXAM. PRIOR TO THE EXAM, THE TECHNOLOGIST PROVIDED A SQUEEZE BALL TO THE PT AND MONITORED THE EXAM. HOWEVER, THE TECHNOLOGIST DID NOT RECEIVE ANY INDICATIONS FROM THE PT OF ANY BURN EXPERIENCE. THE EXAM CONSISTED OF 7 SCANS. THE PULSE SEQUENCES USED WERE: 1OC, FSE.T2 FAT SAT, T2. THE DURATION OF EACH SERIES WAS AS FOLLOWS: 1OC: 0:23MIN, T1: 2:21MIN, T2: 3:16MIN, T2: 3:14MIN, T2: 3:37MIN, AND T2: 2:05MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.0T HD MR LNH GE MEDICAL SYSTEMS, LLC 5110607-2

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other