BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA HDX 1.5T

    MDR report key: 1321808 · Received February 20, 2009

    Report

    Report Number
    2183553-2009-00009
    Event Type
    Injury
    Date Received
    February 20, 2009
    Date of Event
    January 23, 2009
    Report Date
    January 30, 2009
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL GE FIELD ENGINEER VISITED THE SITE AFTER THE INCIDENT AND EVALUATED THE SYSTEM. THE METHODOLOGIES USED AND RESULTS ARE AS FOLLOWS: ENVIRONMENTAL: (INCLUDING COOLING EQUIPMENT, PATIENT AIR COOLING PLUS THE MR SCANNER ERROR LOG) VERIFIED THE GEHC 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 CHECK) VERIFIED THE SURFACE COIL, THE CONNECTIVITY FOR DAMAGE AND CHECKED THE SCANNED ERROR LOG. VERIFIED THE ECG FUNCTIONALITY. SYSTEM/ IMAGE QUALITY: (SYSTEM LEVEL TESTING THE CHECK FOR SYSTEM FAILURES) VERIFIED IMAGES WERE FREE OF IRREGULARITIES. VERIFIED OVERALL SYSTEM STABILITY, SYSTEM SIGNAL TO NOISE RATIO WERE WITHIN SPECIFICATIONS. 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 PATIENT ALAVERIFIED IMAGES WERE FREE OF IRREGULARITIES. VERIFIED OVERALL SYSTEM STABILITY, SYSTEM SIGNAL TO NOISE RATIO WERE WITHIN SPECIFICATION. VERIFIED THE RF POWER OUTPUT, QUADRATURE CHECKS AND POWER MONITORING FUNCTIONALITY WERE WITHIN EXPECTED PERFORMANCE LIMITS. PATIENT MONITORING: (PATIENT ALARM &RF SAFETY MONITOR CHECKS) VERIFIED PT ALARM SYSTEM FUNCTIONS TO SPECIFICATION. VERIFIED PT INTERCOM. NO ISSUES WERE DETECTED. ENGINEERING CONCLUDED THAT THE SYSTEM IS PERFORMING THE SPECIFICATION. THE STEREOTACTIC FRAME IS A LEKSELL, WHICH IS MANUFACTURED BY ELEKTA. (CORPORATE HEAD OFFICE).

    Description of Event or Problem · 1

    A SEDATED PT REPORTEDLY WAS SCANNED ON A MR SCANNER WITH A STEREOTACTIC GAMMA KNIFE FRAME AND SUSTAINED A BLISTER THE SIZE OF 2.5 CM ON THE TEMPLE AREA WHERE THE BASE OF THE SCREW WAS LOCATED. THE PULSE SEQUENCE AND DURATIONS USED FOR THE EXAM WERE: FGR:14 SECONDS, T2 FLAIR: 6 MINS 25 SECS, FSE-XL: 11 MINS 59 SECS. SAR VALUES WERE: FGR PEAK SAR 0.5, T2 FAIR PEAK SAR 1.0, FSE-XL PEAK FLAIR SAR 6.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA HDX 1.5T LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other