BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E.CAM, SYMBIA E

    MDR report key: 2655742 · Received July 13, 2012

    Report

    Report Number
    1423253-2012-00002
    Event Type
    Injury
    Date Received
    July 13, 2012
    Date of Event
    June 11, 2012
    Report Date
    June 12, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP
    Product Code
    KPS
    PMA / PMN Number
    K992731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MODEL NUMBERS: 04380221, 05242826, 05977066, 05977074, 05984005, 05989079, 05989087, 05989095, 05991109, 05991117, 05992099, 07324119, 07324135, 07324143, 07324150, 07760809, 07760932, 07761161, 07823946, 07823953, 07823979, 10151531, 10151532, 10275879, 10413009, 10520745. PMA/510(K): SYMBIA E SINGLE/DUAL: K072567, K082506.

    Description of Event or Problem · 1

    DURING A COLLIMATOR CHANGE ON A GAMMA CAMERA, THE CUSTOMER DID NOT TAKE CARE TO ENSURE PROPER ALIGNMENT AS PER THE USE INSTRUCTIONS. AS A RESULT, THE COLLIMATOR BEGAN TO DROP TO THE FLOOR. THE CUSTOMER WAS IN THE PROCESS OF PUSHING THE COLLIMATOR OFF THE CART. WHEN THE COLLIMATOR BEGAN TO FALL OFF THE CART, THE CUSTOMER WAS PULLED FORWARD AND THERE WAS IMPACT WITH THE SYSTEM. THE CUSTOMER REC'D AN INJURY TO THE FACE THAT REQUIRED STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E.CAM, SYMBIA E GAMMA CAMERA KPS SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP 04380213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other