BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNETOM SKYRA

    MDR report key: 6184876 · Received December 19, 2016

    Report

    Report Number
    2240869-2016-06061
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 20, 2016
    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

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE CAUSE OF THIS EVENT WAS THE INTRODUCTION OF FERROMAGNETIC PIECES INTO THE MR EXAMINATION ROOM AND THEREFORE, A USER ERROR. DUE TO THE STRONG MAGNETIC FIELD, PARTICULAR SAFETY MEASURES HAVE TO BE ADHERED TO IN ORDER TO PREVENT INJURIES. THE MAGNETOM SKYRA SYSTEM MANUAL SECTION AND THE MAGNETOM SYSTEM OWNER MANUAL SECTION PROVIDE CLEAR INSTRUCTIONS AND WARNINGS REGARDING BOTH MAGNETIC FIELD HAZARDS AND TRAINING OF PERSONNEL WITH REGARDS TO MR SAFETY. SPECIAL WARNING SIGNS ARE POSTED AT THE ENTRANCE OF THE CONTROLLED ACCESS AREA (MAGNET ROOM). 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 MAGNETIZABLE OBJECTS INTO THE MAGNETIC FIELD IS CONTRARY TO THE STATEMENTS GIVEN IN THE OPERATING INSTRUCTIONS. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A NURSE SUFFERED AN INJURY WHILE OPERATING THE MAGNETOM SKYRA SYSTEM. A NURSE ENTERED THE MAGNET ROOM WITH A FERROMAGNETIC OXYGEN BOTTLE WHICH WAS IMMEDIATELY ATTRACTED TO THE MAGNET. THE NURSE SUSTAINED AN ABRASION TO HER RIGHT THUMB AS WELL AS PRESSURE PAIN TO THE ABDOMEN. THE NURSE WAS TRANSFERRED AND EVALUATED IN THE CLINIC, HOWEVER, NO FURTHER INFORMATION CONCERNING THE INJURY OR MEDICAL TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836651 MAGNETOM SKYRA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH SIEMENS HEALTHCARE GMBH 10432915

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization