BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E.CAM, SYMBIA E

    MDR report key: 3089470 · Received April 16, 2013

    Report

    Report Number
    1423253-2013-00001
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 3, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    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 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. ADD'L 510(K)S: K072567, K082506. EVAL RESULT: CUSTOMER USING DEVICE ON UNEVEN FLOOR. THIS IS USE THAT IS NOT ACCORDING TO PRODUCT SPECS.

    Description of Event or Problem · 1

    DURING COLLIMATOR CHANGE WHILE REMOVING COLLIMATOR CART, THE CART FELL OVER AFTER REAR CASTERS FELL OUT. HIGH ENERGY COLLIMATORS FELL TO THE FLOOR. CART DAMAGED. COLLIMATOR DAMAGE UNK AT THIS TIME. FLOOR IS NOT LEVEL. THERE WAS NO INJURY. INJURY TO PT IS NOT POSSIBLE. COLLIMATOR CHANGING IS DONE DURING CALIBRATION, SET UP AND/OR SERVICE OF EQUIPMENT. THERE IS NO PT SCANNING DURING COLLIMATOR CHANGE. THE COLLIMATOR CART IS AN ACCESSORY TO THE DEVICE. FROM THE INVESTIGATIVE INFO WE HAVE THUS FAR, WE BELIEVE THAT THE ROOT CAUSE OF THE WHEELS FALLING OFF ARE A COMBINATION OF LOOSE SET SCREWS AND THEN THE WHEELS BEING LIFTED OFF THE FLOOR TO ALLOW THE WHEELS TO FALL. WHEN THE WHEELS FELL OFF, THE CART BECAME UNSTABLE AND TIPPED OVER. WE BELIEVE THAT THE WHEELS WERE LIFTED OFF THE FLOOR UNEVENLY BECAUSE THE CUSTOMER FLOORING IS UNEVEN (DIVOTS AND SLOPING). OUR INVESTIGATION IS ON-GOING AS TO THE ROOT CAUSE OF THE LOOSE SET SCREWS. WE HAVE NOT YET DETERMINED WHAT STEPS WILL BE TAKEN GOING FORWARD AS WE HAVE NOT YET COMPLETED OUR INVESTIGATION. WE HAVE DETERMINED THAT THERE IS A REMOTE POSSIBILITY OF INJURY TO AN OPERATOR. IF THE COLLIMATOR WERE TO FALL ONTO AN OPERATOR, A SERIOUS INJURY IS POSSIBLE. WHILE WE DO NOT CONSIDER SERIOUS INJURY LIKELY, FOR CONSISTENCY PURPOSES WE ARE REPORTING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163299 E.CAM, SYMBIA E CAMMA CAMERA KPS SIEMENS MEDICAL SOLUTIONS USA, INC. 04380213

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other