BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MR TWINSPEED

    MDR report key: 2571570 · Received May 7, 2012

    Report

    Report Number
    2183553-2012-00019
    Event Type
    Malfunction
    Date Received
    May 7, 2012
    Date of Event
    April 10, 2012
    Report Date
    April 10, 2012
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K012200
    Removal / Correction Number
    2183553-10/13/10-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION HAS CONFIRMED TWO PRIMARILY ROOT CAUSES: COMPONENTS IN THE GRADIENT CABLE FIELD ACTION KIT (B)(4) WERE WITHIN SPECIFICATIONS, BUT IMPROPERLY INSTALLED AT THIS SITE. IN ADDITION, AFTER SERVICING THE SCANNER, A DAILY AUTOMATED QUALITY ASSURANCE (DQA) WAS NOT PERFORMED BY THE GE HEALTHCARE FIELD ENGINEER WHICH WOULD CONFIRM PROPER CONNECTION OF THE GRADIENT CABLES. THE GRADIENT CABLE FIELD ACTION KIT HAS BEEN RE-INSTALLED ON THIS SCANNER AND A DQA WAS PERFORMED BY A GE HEALTHCARE FIELD ENGINEER, CONFIRMING CORRECTION OF THIS ISSUE. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE MR TECHNOLOGIST THAT SIX PATIENTS OVER TWO DAYS HAD IMAGES THAT WERE FLIPPED LEFT-TO-RIGHT. ON MONDAY, THREE PATIENTS WERE SCANNED (2 CERVICAL SPINES AND ONE LUMBAR SPINE). ON TUESDAY, THREE PATIENTS WERE SCANNED (TWO CERVICAL SPINES AND ONE LUMBAR SPINE). THE LUMBAR SPINE PATIENT WITH A HISTORY OF TRAUMA, HAD A KNOWN FRACTURE ON THE LEFT ILIAC WING. THE CORONAL SPIN-ECHO SEQUENCE PERFORMED ON THE PATIENT SHOWED THAT THE FRACTURE WAS DISPLAYING ON THE PATIENT'S RIGHT (RT) SIDE. THE MR TECHNOLOGIST CONFIRMED THE FRACTURE SHOULD BE ON THE LEFT SIDE FROM X-RAYS TAKEN OF THE PATIENT'S PELVIS/HIPS. THE RADIOLOGIST WAS NOTIFIED AND ALL EXAMS PERFORMED ON MONDAY AFTERNOON AND TUESDAY MORNING HAD ADDENDUMS ADDED TO ALL SIX SCANS PERFORMED STATING THAT THE IMAGES WERE SWAPPED. THE MR TECHNOLOGIST ALSO ADDED NOTES TO THE PATIENT'S EXAMS IN THE SITE'S PACS SYSTEM. NO PATIENTS SCANNED HAD BEEN SEEN BY THE REFERING PHYSICIANS FOR FOLLOW UP'S SINCE THEIR MR SCANS. NO MISDIAGNOSIS OR MISTREATMENT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MR TWINSPEED MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1