BEUDAMED
    FDA Adverse Event Injury Summary report: N

    14.0 HDX 1.5T

    MDR report key: 1064774 · Received June 24, 2008

    Report

    Report Number
    2183553-2008-00026
    Event Type
    Injury
    Date Received
    June 24, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 28, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND IT TO BE PERFORMING WITHIN SPECIFICATIONS. THE FE ALSO INSPECTED THE COIL AND IDENTIFIED NO ISSUE. THE SYSTEM'S OPERATOR MANUAL PROVIDES THE USER INFO OF TISSUE HEATING DURING AN MR EXAM, AS WELL AS INSTRUCTIONS OF PROPER PT POSITIONING AND PADDING. THE SITE WAS AWARE OF PROPER PADDING INSTRUCTIONS.

    Description of Event or Problem · 1

    A PT SUSTAINED A 2ND- DEGREE BURN ON THE LEFT POSTERIOR ELBOW AFTER A MRI CERVICAL AND THORACIC SPINE EXAM. THE EXAM USED AN 8-CHANNEL CTL ARRAY AND CONSISTED OF 19 SCANS. THE FOLLOWING PULSE SEQUENCES ( WITH DURATIONS IN MINS) WERE USED: FGR 3 PL LOC 0:23, FSE-XL SAG T2 3:08, FSEIR SAG 4:48, FSE-XL SAG 4:00, MERGE AXIAL 8:34, ASSET CALIBRATION, FSE-XL COR T1 0:60, FSE-XL AXIAL T1 2:30, FSE-XL AXIAL T2 4:56, SE T1 SAG 1:12, FSE-XL SAG T2 2:30, FSEIR SAG 3:10 FSE-XL T1 1:46, FSE-XL SAG T1 1:46, FSE-XL AXIAL T2 4:51, FSEIR SAG 3:10, FSE-XL AXIAL T1 6:06, FSE-XL, FSE-XL AXIAL T1 3:57, FSE -XL SAG T1 2:38. THERE WAS NO CONDUCTIVE OBJECT NEAR THE PT AT THE TIME OF THE INCIDENT. THE PT WAS NOT SEDATED. ACCORDING TO THE SITE, THE TECHNOLOGIST USED A SHEET AS PADDING FOR THE PT DUE TO THE PT'S SIZE. AFTER THE EXAM, THE PT COMPLAINED ABOUT THE BURN. THE PT RECEIVED MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 14.0 HDX 1.5T LNH GE MEDICAL SYSTEMS, LLC 2294302 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other