BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMUS HI

    MDR report key: 2944261 · Received January 10, 2013

    Report

    Report Number
    2910081-2013-11703
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY
    Product Code
    IYE
    PMA / PMN Number
    K993425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMEN'S CUSTOMER SERVICE ENGINEERS ARE TRAINED TO POWER DOWN THE SYSTEM BEFORE STARTING REPAIRS/UPGRADES, WHICH WAS THE ACTION TAKEN PRIOR TO THE ISSUE OF THIS REPORTED INCIDENT. THERE ARE ALSO WARNINGS IN THE USER MANUAL, SERVICE MANUALS AND STICKERS AT THE SYSTEM ABOUT THE DANGER OF ELECTROCUTION. A NEW CHARGE DRAWER FOR THE EMI UPGRADE HAS BEEN ORDERED FOR THE CUSTOMER. (B)(6).

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED ON (B)(4) 2012 THAT SIEMENS CSE HAD PROPERLY INSTALLED THE EMI UPGRADE KIT THAT THE CUSTOMER ORDERED. THE CSE HEARD THE GURGLING SOUND OF RUNNING WATER WHEN HE HOOKED THE FACILITY WATER TO THE CHARGE DRAWER, WHICH IS NORMAL. AFTER A FEW MINUTES WATER POURED OUT OF THE PULSE TANK BENEATH THE CHARGE DRAWER. FURTHER INVESTIGATION SHOWED LEAKAGE COMING FROM THE CHARGE DRAWER. WATER WAS SPLASHING ALL AROUND. A NEW (EMI READ) CHARGE DRAWER WAS ORDERED. THERE IS NO PATIENT INVOLVEMENT AND NO REPORT OF INJURY TO SERVICE OR FACILITY PERSONNEL. THIS INCIDENT IS BEING REPORTED DUE TO THE ABILITY OF A WET SURFACE TO PRESENT A CONDUCTIVE PATH FOR ELECTRICAL SHOCK OR ELECTROCUTION. THIS REPORTED INCIDENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14129 PRIMUS HI ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY 04504200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 SW VERSION: ACTV