BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ODYSSEY

    MDR report key: 1645678 · Received March 12, 2010

    Report

    Report Number
    2032139-2010-00001
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Date of Event
    February 19, 2010
    Report Date
    March 11, 2010
    Manufacturer
    PERMEDICS, INC.
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN URGENT MEDICAL DEVICE CORRECTION LETTER WILL BE DISTRIBUTED TO ALL AFFECTED CUSTOMERS BY MARCH 18, 2010, WITH A DESCRIPTION OF THE ANOMALY AND USER CORRECTIVE ACTION STEPS. THE LETTER WILL ALSO BE DISTRIBUTED TO THE PERMEDICS SALES ORGANIZATIONS, INFORMING THEM OF THE ISSUE. A MANDATORY UPGRADE WILL BE PROVIDED BY MAY 19, 2010, AT NO CHARGE. IN THE MEANTIME, THE FOLLOWING RECOMMENDATIONS ARE PROVIDED; INVALID CHARACTERS IN PATIENT ID ERROR, IT IS RECOMMENDED THAT THE USERS DO NOT CREATE PATIENT ID'S THAT CONTAIN CHARACTERS OTHER THAN LETTERS OR NUMBERS.

    Description of Event or Problem · 1

    ANOMALY, INVALID CHARACTERS IN PATIENT ID ERROR: CURRENTLY, ODYSSEY CONSIDERS A VALID ID TO BE COMPRISED OF NUMBERS AND/OR LETTERS. IF A PATIENT ID IN A STUDY CONTAINS A CHARACTER OTHER THAN A LETTER OR NUMBER (INCLUDING SPACES), ODYSSEY REMOVES THE INVALID CHARACTER WHEN MOVING IT TO A PATIENT FOLDER. DUE TO THIS, IT IS POSSIBLE THAT TWO DIFFERENT PATIENT STUDIES COULD BE LISTED WITHIN ODYSSEY FOR ONE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ODYSSEY RADIATION TREATMENT PLANNING SYSTEM MUJ PERMEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1