BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES

    MDR report key: 2680846 · Received August 3, 2012

    Report

    Report Number
    1423253-2012-00003
    Event Type
    Injury
    Date Received
    August 3, 2012
    Date of Event
    June 28, 2012
    Report Date
    July 2, 2012
    Manufacturer
    SIMENS MEDICAL SOLUTIONS, USA, INC. MI GROUP
    Product Code
    KPS
    PMA / PMN Number
    K992731
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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, 10275007, 10275008, 10275009, 10275010. THERE ARE FOUR APPLICABLE 510 (K): SYMBIA E SINGLE/DUAL: K072567, K0825D6. SYMBIA S AND T SERIES: K082506.

    Description of Event or Problem · 1

    DURING A ROUTINE SCAN BEING ACQUIRED ON A GAMMA CAMERA, THE PT ROLLED OFF THE PT PALLET (BED). THE PT SUSTAINED A BROKEN THUMB. THE EXAMINATION OF THE PT PALLET (BED) DID NOT REVEAL ANY DEFECTS, DAMAGE, MISALIGNMENT OR EVIDENCE THAT THE PT PALLET (BED) WAS UNBALANCED. THE OPERATOR STATED THAT THE PT APPEARED TO HAVE A GREATER MASS ON HIS RIGHT SIDE (THE DIRECTION OF THE FALL).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention