BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E.CAM, SYMBIA E

    MDR report key: 3122530 · Received May 16, 2013

    Report

    Report Number
    1423253-2013-00002
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 26, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPS
    PMA / PMN Number
    K992731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFFECTED 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. THERE ARE THREE (3) APPLICABLE 510 (K): SYMBIA E SINGLE/DUAL: K072567, K082506.

    Description of Event or Problem · 1

    AFTER COMPLETION OF STATIC SCAN, THE PT GRABBED THE SIDE OF THE ARM SUPPORT WITH THE LEFT HAND WHILE OPERATOR WAS MANUALLY PULING THE PALLET OUT FROM GANTRY. THE OPERATOR DID NOT CHECK OR SECURE THE PT TO ENSURE ALL BODY PARTS WERE CLEAR OF THE MOVING PARTS BEFORE PULLING THE PALLET. THE PT'S LITTLE FINGER OF THE LEFT HAND WAS CAUGHT UNDER THE ARM SUPPORT AND SHE SUFFERED LACERATIONS (ABOUT 1 CM IN LENGTH) ON HER LITTLE FINGER OF THE LEFT HAND. THE LACERATION REQUIRED AN UNDISCLOSED NUMBER OF STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217859 E.CAM, SYMBIA E GAMMA CAMERA KPS SIEMENS MEDICAL SOLUTIONS USA, INC. 04380213

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other