BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA MR/I HISPEED 1.5T

    MDR report key: 1237268 · Received November 19, 2008

    Report

    Report Number
    2183553-2008-00055
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 20, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K962061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM IS DESIGNED TO COMPLY WITH IEC INCLUDING THE REQUIREMENTS INTENDED TO MINIMIZE THE LIKELIHOOD OF PT WARMING. THE TECHNOLOGIST THOUGHT USING THE PT STRAP WAS ADEQUATE PROTECTION AND DID NOT USE ANY PADDING BETWEEN THE PT AND THE BORE. THE SYSTEM'S OPERATOR MANUAL PROVIDES INSTRUCTIONS ON PADDING AND PROPER PT POSITIONING TO MITIGATE THIS TYPE OF OCCURRENCE. THE FE EVALUATED THE SYSTEM INVOLVED IN THE INCIDENT AS FOLLOWS: ENVIRONMENTAL: (INCLUDING COOLING EQUIPMENT, PT AIR COOLING PLUS THE MR SCANNER ERROR LOG) VERIFIED THE GE SUPPLIED EQUIPMENT WAS FUNCTIONING WHILE THE PT WAS SCANNED. VERIFIED THE SCANNER DID NOT EXPERIENCE A SYSTEM LEVEL ERROR DURING THE PT SCAN. SURFACE COILS/ACCESSORIES: (SURFACE COIL/ECG CHECKS) VERIFIED THE SURFACE COIL, THE CONNECTIVITY FOR DAMAGE AS WELL AND TO CHECK THE SCANNER ERROR LOG. VERIFIED THE ECG FUNCTIONALITY. SYSTEM/IMAGE QUALITY: SYSTEM LEVEL TESTING TO CHECK FOR SYSTEM FAILURES) VERIFIED THE IMAGES WERE FREE OF IRREGULARITIES. VERIFIED OVERALL SYSTEM STABILITY. SYSTEM SIGNAL-TO NOISE RATIO WERE WITHIN SPEC. VERIFIED THE RF POWER OUTPUT, QUADRATURE CHECKS AND POWER MONITORING FUNCTIONALITY WERE WITHIN EXPECTED PERFORMANCE LIMITS. PT MONITORING: (PT ALARM & RF SAFETY MONITOR CHECKS) VERIFIED PT ALARM SYSTEM FUNCTIONS TO SPEC. VERIFIED PT INTERCOM. NO ISSUES WERE DETECTED WHEN THE TESTS DESCRIBED ABOVE WERE PERFORMED. ENGINEERING CONCLUDED THE SYSTEM IS PERFORMING TO SPEC.

    Description of Event or Problem · 1

    A SEDATED PT REPORTEDLY SUSTAINED A BURN WITH A BLISTER THE SIZE OF A SILVER DOLLAR ON HIS ELBOW. ACCORDING TO THE TECHNOLOGIST, HE USED A PT STRAP INSTEAD OF PADDING BECAUSE OF THE PT'S SIZE. THE FOLLOWING PULSE SEQUENCE AND DURATION USED IS AS FOLLOWS: SERIES 1: AXIAL TL 4:30; SERIES 2: AXIAL T2 WITH FAT SUPPRESSION 6:00; SERIES 3: COR TL 4:30; SERIES 4: COR T2 5:00; SERIES 5: COR INVERSION RECOVERY 6:30; SERIES 6: SAQ CONE DOWN OVER HIP PROTON DENSITY 5:00; SERIES 7: AXT1 PRE-CONTRAST WITH FAT SUPPRESSION 6:30; SERIES 8: AXT1 POST-CONTRAST WITH FAT SUPPRESSION 6:30; SERIES 9: COR T1 POST-CONTRAST WITH FAT SUPPRESSION 6:00. NO SAR VALUES PROVIDED. THE PT WAS TREATED WITH SILVADENE CREAM AND THE ELBOW WAS BANDAGED BY THE USER FACILITY. NO FURTHER MEDICAL TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA MR/I HISPEED 1.5T LNH GE MEDICAL SYSTEMS, LLC 2138300-19 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other