BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCEPTRE/ECAT EMERGE

    MDR report key: 826268 · Received February 9, 2007

    Report

    Report Number
    1034973-2007-00001
    Event Type
    Other
    Date Received
    February 9, 2007
    Date of Event
    January 3, 2007
    Report Date
    January 4, 2007
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON OUR INVESTIGATION, WE DETERMINED ON 01/10/07, THERE WAS NO POTENTIAL SAFETY RISK DUE TO THE AMOUNT OF HIGH VOLTAGE THAT IS PRESENT (1050 VOLTS). NO INJURIES HAVE BEEN REPORTED. HOWEVER, SHOULD THIS ISSUE RECUR; IT COULD POTENTIALLY CAUSE A SERIOUS INJURY. BASED ON OUR INVESTIGATION AND COMMUNICATION WITH THE SERVICE ENGINEER, THIS PROBLEM IS DUE TO A FAULTY RELAY ON THE COINCIDENCE PROCESSOR/CONTROL BOARD. THE COMMUNICATION IS SENT TO THE COINCIDENCE PROCESSOR/CONTROL BOARD TO TURN THE HIGH VOLTAGE OFF. THE COINCIDENCE PROCESSOR/CONTROL BOARD RESPONDS THAT IT HAS RECEIVED THE COMMAND, BUT DUE TO THE FAULTY RELAY, THE HIGH VOLTAGE IS NOT TURNED OFF. AFTER THE SERVICE ENGINEER REPLACED, THE COINCIDENT PROCESSOR/CONTROL BOARD, HE WAS ABLE TO SUCCESSFULLY TURN THE HIGH VOLTAGE ON/OFF BY USING THE GANTRY SETTINGS SOFTWARE COMMAND. AS OUR CORRECTIVE ACTION, A FIELD UPGRADE WILL BE RELEASED WHICH WILL DISABLE THIS SOFTWARE COMMAND. THE SERVICE ENGINEER WILL NOT BE ABLE TO USE THE GANTRY SETTINGS TO TURN THE HIGH VOLTAGE ON/OFF. ADDITIONALLY, THE SERVICE MANUALS WILL BE UPDATED TO REFLECT THIS CHANGE. IN THE INTERIM, A NOTIFICATION WILL BE SENT TO ALL SERVICE ENGINEERS AS A REMINDER TO ALWAYS USE GOOD ENGINEERING PRACTICES AND TO TURN OFF THE POWER WHEN SERVICING THE GANTRY.

    Description of Event or Problem · 1

    A SERVICE ENGINEER REPORTED THAT WHILE PERFORMING SERVICE ON THE PET SCANNER, THE HIGH VOLTAGE ON THE SYSTEM REMAINED ON, EVEN THOUGH THE INDICATOR IN THE GANTRY SETTINGS SOFTWARE STATED THAT IT HAD BEEN TURNED OFF. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCEPTRE/ECAT EMERGE PET SCANNER KPS SIEMENS MEDICAL SOLUTIONS USA, INC. P0008060 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other