BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRICITY RA1000

    MDR report key: 1143714 · Received August 29, 2008

    Report

    Report Number
    3004526608-2008-00042
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 12, 2006
    Report Date
    August 13, 2006
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED LATE, AS THIS ISSUE WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINT FILES. THIS ACTIVITY IS BEING COMPLETED AS PART OF A CORRECTIVE ACTION TAKEN PURSUANT TO AN FDA INSPECTION CONDUCTED AT THE FACILITY IN APRIL 2008. UPON INVESTIGATION, IT WAS DETERMINED THAT THE IMAGE HAD BEEN FLIPPED BY THE USER. THE IMAGE ORIENTATION MARKER WAS PRESENT ON THE IMAGE. HOWEVER, THE MARKER WENT UNNOTICED DURING SURGERY. THIS ISSUE IS BEING ATTRIBUTED TO USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGEON OPERATED ON THE WRONG SIDE OF A PATIENT'S HEAD. UPON INVESTIGATION, IT WAS DETERMINED THAT THE IMAGE HAD BEEN FLIPPED BY THE USER. THE IMAGE ORIENTATION MARKER WAS PRESENT ON THE IMAGE. HOWEVER, THE MARKER WENT UNNOTICED DURING SURGERY. THIS ISSUE IS BEING ATTRIBUTED TO USER ERROR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization