BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNETOM AERA

    MDR report key: 6352250 · Received February 23, 2017

    Report

    Report Number
    2240869-2017-64568
    Event Type
    Injury
    Date Received
    February 23, 2017
    Date of Event
    October 19, 2016
    Report Date
    February 20, 2017
    Manufacturer
    SIEMENS HEALTHCARE, MAGNETIC RESONANCE
    Product Code
    LNH
    PMA / PMN Number
    K141977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLETE EXAMINATION OF THE PATIENTS ELBOW LASTED 107.7 MIN WITH AN ACTIVE SCANNING TIME OF 95 MIN. NO ABNORMALITY WAS FOUND WHICH WOULD INDICATE A SYSTEM MALFUNCTION. THE COMPLETE MEASUREMENT WAS PERFORMED IN THE NORMAL OPERATING MODE. THE SAR VALUES WERE WITHIN THE LIMITS DEFINED BY THE MR SAFETY STANDARD (IEC 60601-2-33), I.E. THE MAXIMUM APPLIED SAR WAS 99% OF THE NORMAL MODE LIMIT. THE APPLIED RF IN THIS CASE SHOULD NOT REPRESENT A RISK UNDER NORMAL CIRCUMSTANCES AND SCAN CONDITIONS. FURTHERMORE, THE PATIENT ABSORBED 162.6 W MIN/KG WHICH IS BELOW THE LIMIT OF 240 W MIN/KG DEFINED IN THE MR SAFETY STANDARD (IEC 60601-2-33). THE SYSTEM WAS CHECKED BY A SIEMENS SERVICE ENGINEER AND FOUND TO BE WITHIN SPECIFICATION. NO HARDWARE OR SOFTWARE PROBLEM WAS FOUND. THE CONTACT WITH THE BORE WALL IN COMBINATION WITH THE EXTREME LONG DURATION OF THE EXAMINATION WITH NOTABLE RF INTENSITY IS THE ROOT CAUSE FOR THIS INCIDENT. DIRECT CONTACT OF THE TISSUE WITH THE BORE WALL CAN RESULT IN HIGH-FREQUENCY CURRENT LOOPS WHICH ARE CAPABLE OF CAUSING LOCAL BURNS. TO PREVENT THESE POSSIBLE BURNS A WARNING NOTICE IS IMPLEMENTED IN THE MAGNETOM AERA OPERATOR MANUAL - MR SYSTEM SYNGO MR E11 PAGE 20/21, WHICH CONTAINS THE NECESSARY PREVENTIVE MEASURES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A PATIENT SUFFERED AN INJURY FOLLOWING AN EXAMINATION ON THE MAGNETOM AERA SYSTEM. THE PATIENT UNDERWENT A SCAN OF THE ELBOW LASTING 107.7 MINUTES WITH AN ACTIVE SCANNING TIME OF 95 MINUTES. THE PATIENT WAS PLACED IN THE MAGNET BORE ASYMMETRICALLY IN ORDER TO BRING THE ELBOW ISO CENTRE WITH THE PATIENTS LEFT FLANK IN DIRECT CONTACT WITH THE BORE WALL. IMMEDIATELY FOLLOWING THE EXAM, A BLISTER APPROXIMATELY 4 INCHES IN DIAMETER WAS NOTICED ON THE PATIENTS SIDE. THE PATIENT WAS REFERRED TO A WOUND SPECIALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134554 MAGNETOM AERA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH SIEMENS HEALTHCARE, MAGNETIC RESONANCE 10432914

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization