BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNETOM AERA

    MDR report key: 6633181 · Received June 12, 2017

    Report

    Report Number
    3002808157-2017-02880
    Event Type
    Injury
    Date Received
    June 12, 2017
    Date of Event
    May 15, 2017
    Report Date
    May 17, 2017
    Manufacturer
    SIEMENS HEALTHCARE GMBH, MR QT
    Product Code
    LNH
    PMA / PMN Number
    K132951
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2017014. (B)(4) IS SUBMITTING THE REPORT ON BEHALF OF SIEMENS (B)(4), ERLANGEN (MANUFACTURER). THE SYSTEM WAS CHECKED BY A SIEMENS SERVICE ENGINEER AND FOUND TO BE OPERATING WITHIN SPECIFICATION. NO CAUSE FOR THE PATIENTS INJURY COULD BE DETERMINED AS NO ELEMENT WAS IN CONTACT WITH THE HEELS. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT A PATIENT SUFFERED AN INJURY FOLLOWING EXAMINATION ON THE MAGNETOM AERA SYSTEM. DURING A RIGHT KNEE STUDY, THE PATIENT COMPLAINED OF PAIN IN THE HEELS BEFORE AND AFTER THE EXAMINATION. THE PATIENT WAS POSITIONED FEET FIRST SUPINE AND THE LEGS WERE NOT CROSSED. THE OPERATOR DID NOT OBSERVE ANY AREAS OF REDNESS ON THE HEELS FOLLOWING THE EXAMINATION. FOLLOWING THE EXAMINATION, THE PATIENTS FAMILY REPORTED SECOND AND THIRD DEGREE BURNS TO THE HEELS WHICH REQUIRED SKIN TRANSPLANTATION. NO FURTHER INFORMATION REGARDING THE STATE OF HEALTH OF THE PATIENT INVOLVED WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414342 MAGNETOM AERA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH SIEMENS HEALTHCARE GMBH, MR QT 10432914

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other