BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOR IMPRESSION PLUS

    MDR report key: 863752 · Received March 19, 2007

    Report

    Report Number
    2910081-2007-00010
    Event Type
    Malfunction
    Date Received
    March 19, 2007
    Date of Event
    March 30, 2005
    Report Date
    March 30, 2005
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K993425
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A PRODUCT ISSUE HAS BEEN DISCOVERED ON THE ELECTRONIC IMAGING DEVICE (EID) DURING PATIENT SETUP. PATIENT WAS ON TOP OF THE TREATMENT TABLE DURING THIS INCIDENT, BUT WAS NOT INJURED. THE OPERATOR EXTENDED THE EID USING THE MOTION ENABLE SWITCHES. THE EID REPORTEDLY CONTINUED TO MOVE AFTER THE OPERATOR RELEASED THE MOTION ENABLE SWITCHES. THE EID MOTION WAS HALTED WHEN IT COLLIDED TO UNDERSIDE OF THE TREATMENT TABLE. IT WAS DISCOVERED BY SERVICE THAT THE EID WAS MISS-WIRED DURING THE INITIAL INSTALLATION. IT IS IMPORTANT TO NOTE THAT THE SCHEMATIC FOR THE THIS DEVICE IS LABELED CORRECTLY. UPON INITIAL REVIEW OF THIS INCIDENT, A REPORTING DECISION WAS PERFORMED WHICH EVALUATED THE PRECUSSIONS IF THIS INCIDENT WAS TO RECUR. AS A DEATH OR SERIOUS INJURY APPEARED UNLIKELY, THIS ISSUE HAD BEEN DEEMED NOT REPORTABLE. HOWEVER, AS RESULT OF RE-EVALUATED OF THIS INCIDENT, A DECISION HAS BEEN MADE TO REPORT THIS ISSUE IN THE ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCOR IMPRESSION PLUS ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *