BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAGLIFE C

    MDR report key: 660144 · Received December 9, 2005

    Report

    Report Number
    660144
    Event Type
    Other
    Date Received
    December 9, 2005
    Date of Event
    October 4, 2005
    Report Date
    December 9, 2005
    Manufacturer
    SCHILLER AMERICA, INC.
    Product Code
    MHX
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    MRI WAS PERFORMED UNDER ANESTHESIA WITH CONSCIOUS SEDATION. PATIENT WAS CONNECTED TO SCHILLER MONITOR TO OBTAIN VITAL SIGNS DURING MRI PROCEDURE. AFTER THE PROCEDURE WAS COMPLETED, A NURSE IN THE OPERATING ROOM NOTIFIED MRI TECHNOLOGIST THAT THE PATIENT HAD SOME FORM OF SKIN IRRITATION. PATIENT WAS TREATED WITH SILVADENE CREAM IN THE RECOVERY ROOM FOR THE SKIN IRRITATION. PATIENT WAS DISCHARGED FROM THE RECOVERY UNIT TO HOME.

    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 E-TRODE ECG ELECTRODE DRX CONMED CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR