BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIEMENS BRAND NAME: MEVATRON

    MDR report key: 1791932 · Received August 3, 2010

    Report

    Report Number
    2910081-2010-00030
    Event Type
    Other
    Date Received
    August 3, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K882729
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RISK ANALYSIS INDICATES: SEVERITY: 3 (CRITICAL). THE COMPLAINT BEHAVIOR MAY POTENTIALLY RESULT IN A SERIOUS INJURY IF THE TREATMENT TABLE STARTS MOVING BY ITSELF TOWARDS THE ACCELERATOR HEAD WHILE A PATIENT IS ON THE TABLE. IT WAS DETERMINED THAT THE PATIENT HAD BEEN SQUEEZED, BUT FORTUNATELY NOT INJURED. IN OTHER CASES A MORE SERIOUS INJURY MAY BE POSSIBLE. PROBABILITY: C (REMOTE) PROBABILITY TO HARM THE PATIENT IS IMPROBABLE. IT'S THE OPERATOR'S TASK TO CLOSELY MONITOR THE PATIENT WHILE THE PATIENT IS ON THE TABLE (SEE THE CORRESPONDING WARNINGS IN THE SYSTEM OPERATOR GUIDE T2-000.620.21.01.02). IN CASE THE OPERATOR SEES THAT THERE IS A PROBLEM OR THE TABLE MOVES UNCONTROLLED, HE HAS TO INTERVENE, E.G. BY PRESSING THE EMERGENCY-POWER-OFF-BUTTON. IN THIS CASE. THE CUSTOMER MISSED TO TURN THE OBSERVATION CAMERA ON AND DID NOT USE THE EMERGENCY STOP BUTTON TO PREVENT A DANGEROUS SITUATION TO THE PATIENT. THE WATER IN THE TABLE BASE IS CONSIDERED AS A ACT OF NATURE BEYOND HUMAN CONTROL. NO OTHER PRODUCTS ARE AFFECTED.

    Description of Event or Problem · 1

    A POTENTIAL PRODUCT ISSUE HAS BEEN REPORTED WITH OUR MEVATRON LINEAR ACCELERATOR. IN THE ABUNDANCE OF CAUTION THIS ISSUE IS BEING REPORTED. WHEN FIRST PATIENT WAS BEING TREATED THE TABLE RAISED UP UNCOMMANDED. THIS CAUSED THE PATIENT TO MAKE CONTACT WITH THE ACCESSORY HOLDER. DURING THE ACCIDENT, THE OPERATOR DIDN'T USE ANY EMERGENCY STOP. THE INVESTIGATOR ARRIVED AT THE HOSPITAL AT 12 AM ON (B)(6) 2010 AND FOUND THAT THE TABLE BASE HAD BEEN IMMERSED BY RAIN. THE INVESTIGATOR COMMENTED THAT THE CONTRACTOR IN THE TABLE BASE MAY HAVE BEEN SHORTED OUT BY THE WATER. THIS COULD HAVE CAUSED THE OIL PUMP WORKED AUTOMATICALLY AND MOVING THE TABLE TOP UP. THERE ARE TWO PRIMARY REASONS FOR THIS EVENT. THE RAIN IN THE TABLE BASE IS THE MAIN REASON; THE DOCTOR NOT OPEN THE MONITOR CAMERA WHEN DO THE TREATMENT; AND THE DOCTOR NOT USE THE EMERGENCY BUTTON AND MANUAL DROP HANDLE OF TABLE CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS BRAND NAME: MEVATRON ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1