BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY RA1000

    MDR report key: 1216358 · Received October 29, 2008

    Report

    Report Number
    3004526608-2008-00089
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 2008
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE BY THE MANUFACTURER, REGARDING THE OUTCOME OF THE PT ASSOCIATED WITH THIS INCIDENT. HOWEVER, THE REPORTER HAS DECLINED TO PROVIDE ANY ADDITIONAL DETAILS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ADULT MALE PT IN THE EMERGENCY ROOM WAS BEING TREATED FOR AN OPEN HEAD INJURY. THE CLINICIANS WERE TRYING TO VIEW AN EXAM TO DETERMINE TREATMENT OF THE PT. HOWEVER, THE EXAM COULD NOT BE VIEWED VIA PACS. AFTER A DELAY IN TREATMENT LASTING APPROXIMATELY 40 MINUTES, THE CLINICIANS WERE ABLE TO VIEW THE EXAM VIA THE MODALITY IN WHICH IT WAS ACQUIRED. THE PT OUTCOME WAS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRICITY RA1000 PICTURE ARCHIVING & COMMUNICATION SYS LLZ GE HEALTHCARE INTEGRATED IT SOLUTIONS RA1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1