BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNETOM SKYRA

    MDR report key: 6854929 · Received September 11, 2017

    Report

    Report Number
    3002808157-2017-94154
    Event Type
    Injury
    Date Received
    September 11, 2017
    Date of Event
    August 20, 2017
    Report Date
    August 30, 2017
    Manufacturer
    SIEMENS HEALTHCARE GMBH, MR QT
    Product Code
    LNH
    PMA / PMN Number
    K141977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2017014. (B)(4). SIEMENS CONDUCTED AN INVESTIGATION INTO THE REPORTED EVENT AND CONCLUDED THAT THE CAUSE OF THE EVENT WAS THE INTRODUCTION OF FERROMAGNETIC PIECES INTO THE MR EXAMINATION ROOM AND A USER ERROR. DUE TO THE STRONG MAGNETIC FIELD, PARTICULAR SAFETY MEASURES HAVE TO BE ADHERED TO IN ORDER TO PREVENT INJURIES. THEREFORE, THE MAGNETOM SKYRA SYSTEM OPERATOR MANUAL SECTION 2 AND THE MAGNETOM SYSTEM OWNER MANUAL SECTION 1 PROVIDE CLEAR INSTRUCTIONS AND WARNINGS REGARDING BOTH MAGNETIC FIELD HAZARDS AND TRAINING OF PERSONNEL WITH REGARDS TO MR SAFETY. THE RESPONSIBILITY TO INSTRUCT PERSONNEL AND PATIENTS WHO HAVE ACCESS TO THE MR EXAMINATION ROOM ABOUT MAGNETIC FIELD HAZARDS LIES WITH THE CUSTOMER. THE MANUALS STATE THAT ONLY EQUIPMENT SPECIFIED OR RECOMMENDED FOR USE IN THE CONTROLLED AREA (MR EXAMINATION ROOM) SHALL BE USED. THE INTRODUCTION OF MAGNETIC OBJECTS INTO THE MAGNETIC FIELD IS CONTRARY TO THE STATEMENTS GIVEN IN THE OPERATING INSTRUCTIONS. FURTHERMORE SPECIAL WARNING SIGNS ARE POSTED AT THE ENTRANCE OF THE CONTROLLED ACCESS AREA (MAGNET ROOM). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT A HOSPITAL WORKER WAS INJURED WHEN ACCESSING THE EXAM ROOM OF THE MAGNETOM SKYRA. THE WORKER BROUGHT AN ALUMINIUM LADDER INTO THE SCAN ROOM, NOT KNOWING THAT THERE WERE ALSO FERROMAGNETIC JOINTS, RESULTING IN THE LADDER BEING DRAWN TOWARDS THE MAGNET. THE WORKER BECAME TRAPPED BETWEEN THE LADDER AND THE MAGNET, BUT WAS ABLE TO FREE HIMSELF WITHOUT THE MAGNET BEING RAMPED DOWN. THE EMPLOYEE SUFFERED A SMALL LACERATION OVER THE RIGHT EYE WHICH REQUIRED STITCHES AND AN UNDISCLOSED INJURY TO THE LEFT ARM THAT DID NOT REQUIRE TREATMENT. NO FURTHER INFORMATION REGARDING FOLLOW UP MEDICAL TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636561 MAGNETOM SKYRA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH SIEMENS HEALTHCARE GMBH, MR QT 10432915

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization