BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T HDX ECHOSPEED

    MDR report key: 3383495 · Received October 1, 2013

    Report

    Report Number
    2183553-2013-00033
    Event Type
    Injury
    Date Received
    October 1, 2013
    Date of Event
    September 3, 2012
    Report Date
    September 2, 2013
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL PT INFO WAS MADE AVAILABLE TO GE HEALTHCARE. DURING AN ON SITE INVESTIGATION INTO THE EVENT REPORTED VIA MDR # 2183553-2013-00028, THE HOSPITAL TEAM INFORMED GE HEALTHCARE THAT THEY HAD A SIMILAR ARM FRACTURE/INJURY ONE YEAR AGO, IN (B)(6) 2012. THE SITE CONFIRMED THAT GE WAS NOT NOTIFIED WHEN THE EVENT OCCURRED IN (B)(6) 2012. GE HEALTHCARE'S INVESTIGATION INCLUDED AN ON SITE EVALUATION OF THE REPORTED EVENT, EVALUATION OF CURRENT LABELING, REVIEW OF TRAINING CONDUCTED AT THE SITE, AND TRENDING OF SIMILAR OCCURRENCES. THROUGH THIS ANALYSIS, IT WAS CONFIRMED THAT RELEVANT PLANNED MAINTENANCE WAS COMPLETED ON (B)(6) 2012. NO ISSUES WITH THE SYSTEM WERE IDENTIFIED AT THIS TIME. SITE APPLICATION TRAINING WAS COMPLETED IN SEPTEMBER 2009. THIS TRAINING INCLUDED SAFE PT PREPARATION/ PATIENT MONITORING AND THE FEATURES OF THIS MR SYSTEM. EXISTING LABELING INCLUDING THE MR SAFETY GUIDE AND GE HEALTHCARE OPERATOR AND SAFETY MANUAL CONTAIN ADEQUATE RECOMMENDATIONS TO ENSURE PT SAFETY. TRENDING CONFIRMED NO OCCURRENCE OF SIMILAR ISSUES, ASIDE FROM THE SIMILAR EVENT REPORTED FROM THIS SITE (MDR 183553-2013-00028). THE ROOT CAUSE ANALYSIS REVEALED LACK OF USE OF THE RECOMMENDED PT SAFETY FEATURES. (PT STRAPS NOT USED, ARM BOARDS NOT LOWERED, MONITORING OF THE PT TO PREVENT INJURY). REVIEW OF SERVICE DOCUMENTATION AND ON SITE EVALUATION CONFIRMED THAT THE PT TABLE, CRADLE AND LONGITUDINAL DRIVE SYSTEMS DID NOT MALFUNCTION. NO FURTHER ACTIONS ARE INDICATED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS UNDERGOING A MRI OF THE HEAD. THE PT WAS NOT SECURED WITH PADDING OR THE STRAPS. THE LEFT ARM BOARD (PT SIDE RIGHT ARM BOARD) WAS KEPT IN HORIZONTAL ORIENTATION. AFTER COMPLETION OF THE SCAN, THE OPERATOR USED THE "HOME" BUTTON TO MOVE THE PT OUT OF THE MAGNET BORE. THE OPERATOR WAS AT THE RIGHT SIDE OF THE TABLE LOOKING AT THE CONTROL PANEL ON THE MAGNET. WHILE THE PT WAS BEING MOVED OUT FROM THE MAGNET BORE, HIS RIGHT ARM SLIPPED OFF THE TABLE. THIS MOVEMENT WAS NOT NOTICED BY THE OPERATOR. AS TEH CRADLE CONTINUED TO MOVE THE ARM WAS OBSTRUCTED BY THE ARM BOARD RESULTING IN A FRACTURE OF THE ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495169 1.5T HDX ECHOSPEED MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other