BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMUS HI

    MDR report key: 3021879 · Received March 26, 2013

    Report

    Report Number
    2910081-2013-01823
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 27, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K993425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS' INVESTIGATION INTO THE REPORTED INCIDENT IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA UPON COMPLETION OF THE INVESTIGATION. (B)(6).

    Description of Event or Problem · 1

    SIEMENS WAS INFORMED ON (B)(6) 2013 THAT THERE IS AN INHERENT PROBLEM WITH ONE VERSION OF THE CAP-BANK DISCHARGE (SAFETY) RELAY WHICH IS INTENDED TO MAKE THE CAPACITOR BANK SAFE AFTER REMOVAL OF THE CHARGE DRAWER FROM THE MACHINE. REPORTEDLY, INVESTIGATION OF THE CHARGE DRAWER THAT WAS REMOVED FROM THE LINAC FOUND THAT 3-PHASE IS APPLIED TO THE DRAWER WHENEVER MODULATOR INCOMPLETE IS INACTIVE (NORMAL OPERATION) THROUGH THE 3X SOFT START RESISTORS DUE TO A RE-DESIGN OF THE PRE-CHARGE CIRCUIT IN THE MAIN POWER PANEL. THE RESULT OF THIS IS THAT THERE IS THE POSSIBILITY OF 3-PHASE POWER STILL BEING APPLIED TO THE CHARGE DRAWER WHEN THE DRAWER IS DISENGAGED FROM THE MACHINE. THERE IS NO REPORT OF MISTREATMENT OR INJURY TO A PATIENT, FACILITY TECHNICIAN OR SERVICE PERSONNEL. THIS REPORTED INCIDENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123832 PRIMUS HI ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC. 04504200

    Patients

    Seq Age Sex Outcome Treatment
    1 CHARGE DRAWER REPLACEMENT KIT - MOD. NO. 05857060| RELAY, AC 120V 1U 10A 600 VAC - MOD. NO. 05504506