BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNETOM SKYRA

    MDR report key: 8539386 · Received April 23, 2019

    Report

    Report Number
    3002808157-2017-00879
    Event Type
    Injury
    Date Received
    April 23, 2019
    Date of Event
    August 26, 2014
    Report Date
    February 13, 2017
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    LNH
    PMA / PMN Number
    K141977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRODES USED ARE LABELED MR CONDITIONAL BY THE MANUFACTURER; HOWEVER, THE USE OF THE ELECTRODES IS NOT APPROVED BY SIEMENS (UNILECT TM 4841P ELECTRODES, UNOMEDICAL LTD. (B)(4)). (B)(6).

    Description of Event or Problem · 1

    SIEMENS BECAME AWARE OF AN ADVERSE EVENT INVOLVING A SIEMENS MAGNETOM SKYRA SYSTEM THROUGH AN ARTICLE PUBLISHED IN THE JOURNAL OF RADIOLOGY AND IMAGING. AN UNUSUAL CASE OF A THIRD DEGREE SKIN BURN WAS REPORTED USING MRI ELECTROCARDIOGRAPHIC LEADS. THE ELECTRODES ARE LABELED MR CONDITIONAL BY THE MANUFACTURER, HOWEVER, THE ELECTRODES ARE NOT A SIEMENS APPROVED PRODUCT. THE VENDOR OF THE ELECTRODES WAS INFORMED BY THE USER WHEN THE INCIDENT OCCURRED, HOWEVER, SIEMENS WAS NOT INFORMED OF THE INCIDENT AS NO MALFUNCTION OF THE SIEMENS SYSTEM WAS OBSERVED. THE PATIENT WAS TREATED WITH AQUAGEL AND A FOAM BANDAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333763 MAGNETOM SKYRA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH SIEMENS HEALTHCARE GMBH 10432915

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other