BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNA 0.7T OPENSPEED WITH EXCITE

    MDR report key: 2321533 · Received October 27, 2011

    Report

    Report Number
    2183553-2011-00037
    Event Type
    Malfunction
    Date Received
    October 27, 2011
    Date of Event
    September 30, 2011
    Report Date
    October 27, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC.
    Product Code
    LNH
    PMA / PMN Number
    K032795
    Removal / Correction Number
    2183553-10/13/10-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION DETERMINED THAT, IF AN MR SYSTEM'S GRADIENT CABLES ARE INADVERTENTLY SWAPPED WHILE SERVICING THE GRADIENTS, AND THE SERVICE ENGINEER DOES NOT PERFORM THE GEOMETRY CHECK AS REQUIRED IN THE SERVICE PROCEDURE, IMAGES MAY BE FLIPPED LEFT-RIGHT WITH INCORRECT ORIENTATION ANNOTATION. AN URGENT MEDICAL DEVICE CORRECTION LETTER WAS SENT TO CUSTOMER WITH AFFECTED UNITS INFORMING THEM OF THE REPORTED ISSUE. IN ADDITION, A FIELD ENGINEER WILL INSTALL A DEVICE ON ALL AFFECTED UNITS WHICH WILL REDUCE THE POTENTIAL FOR THE GRADIENT CABLES TO BE SWAPPED. THE SITE INVOLVED IN THE REPORTED COMPLAINT WAS SENT THE CUSTOMER LETTER AND IS SCHEDULED TO HAVE A FIELD ENGINEER INSTALL THE CABLE KEYING (MECHANICAL INTERFERENCE) AS PART OF THE FIELD ACTION. THIS ACTION HAS BEEN REPORTED TO FDA PER SA CFR PART 806 ON (B)(4) 2010. REFERENCE CORRECTIONS AND REMOVALS REPORT NUMBER 2183553-10/13/10-002-C.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICING OF A SIGNA 0.7 T OPENSPEED MR SCANNER, THE GRADIENT CABLES WERE SWAPPED ACCIDENTALLY THE NIGH BEFORE. THIS CAUSED THE IMAGES OF 4 PTS TO BE FLIPPED IN THE LEFT TO RIGHT DIRECTION AND THE PT ORIENTATION ANNOTATION TO BE INCORRECT. THERE WAS NO MISDIAGNOSIS OR MISTREATMENT AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA 0.7T OPENSPEED WITH EXCITE MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1