BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOSTAR SPICA 1.5T MRI

    MDR report key: 4943252 · Received July 27, 2015

    Report

    Report Number
    3009885280-2015-00003
    Event Type
    Injury
    Date Received
    July 27, 2015
    Date of Event
    June 30, 2015
    Report Date
    July 27, 2015
    Manufacturer
    ALLTECH MEDICAL SYSTEMS AMERICA, INC.
    Product Code
    LNH
    PMA / PMN Number
    K113511
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY HAS NOT SHARED ANY FURTHER DETAILS AT THIS TIME. WHEN AN INVESTIGATION CAN BE COMPLETED A FOLLOW-UP REPORT WILL BE SENT. DEVICE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    AN ALLTECH EMPLOYEE HEARD THROUGH A FACILITY EMPLOYEE THAT THERE WAS A INCIDENT OF A PATIENT FALLING. THE FACILITY WOULD NOT CONFIRM THE EVENT HAPPENED AND NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486215 ECHOSTAR SPICA 1.5T MRI MAGNETIC RESONANCE IMAGING LNH ALLTECH MEDICAL SYSTEMS AMERICA, INC. 2011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other