BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAGLIFE C

    MDR report key: 663155 · Received December 12, 2005

    Report

    Report Number
    663155
    Event Type
    Other
    Date Received
    December 12, 2005
    Date of Event
    December 5, 2005
    Report Date
    December 12, 2005
    Manufacturer
    SCHILLER AMERICA, INC.
    Product Code
    MHX
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN MRI OF THE PELVIS WITH ANESTHESIA. MRI WAS COMPLETED ACCORDING TO PHYSICIAN'S ORDER. ECG PADS WERE REPOSITIONED DURING THE MRI PROCEDURE ON LEFT AND RIGHT SIDES. ADJUSTMENT OF THE ECG PADS WAS MADE 9-12 MINUTES INTO PROCEDURE, PER MRI TECHNOLOGIST DUE TO THE POOR SIGNAL TRACE. MRI TECHNOLOGIST AND CRNA JOINTLY MADE ADJUSTMENT AND FURTHER SCANNING WAS DONE. TOTAL SCAN TIME FOR THE PATIENT WAS AROUND 25-30 MINUTES. THE ENTIRE MRI PROCEDURE SPANNED FROM APPROXIMATELY 8:00 AM TO 9:30 AM. FOLLOWING THE MRI PROCEDURE, THE RECOVERY ROOM NOTIFIED THE MRI DEPARTMENT BECAUSE THE PATIENT HAD DEVELOPED SOME FORM OF SKIN IRRITATION TO THE ECG PADS. THE PATIENT HAD FIVE AREAS OF IRRITATION, ONE AT THE CENTER OF THE STERNUM AND TWO ON THE RIGHT SIDE AND ANOTHER TWO ON THE LEFT SIDE. PERFORMED ALL SAFETY CHECKS ON MONITOR. IN PARTICULAR, ECG LEAKAGE CURRENT WAS WITHIN MANUFACTURER'S SPECIFIED LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGLIFE C PHYSIOLOGICAL MONITOR, MRI COMPATIBLE MHX SCHILLER AMERICA, INC. MAGLIFE C PLUS *
    2 CLEARTRACE ECG ELECTRODES DRX CONMED ELECTROSURGERY CLEARTRACE 2700 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR