BEUDAMED
    FDA Adverse Event Other Summary report: N

    CA1000

    MDR report key: 1960039 · Received January 7, 2011

    Report

    Report Number
    9681779-2011-00001
    Event Type
    Other
    Date Received
    January 7, 2011
    Report Date
    December 10, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K063628
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CENTRICITY CARDIOLOGY CA1000 MEASUREMENT CALCULATIONS ARE NOT CORRECT. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE CUSTOMER IS PERFORMING THEIR MEASUREMENTS INCORRECTLY RESULTING IN INCORRECT INFO BEING ENTERED INTO THE CA1000 TO PERFORM THE CALCULATION. THE STUDY WAS SENT FROM THE CATH LAB TO AN ENTERPRISE ARCHIVE (EA) FOR STORAGE AND THEN PULLED FROM THE EA TO A CA1000 WORKSTATION FOR REVIEW. THERE WAS NO REPORTED PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CA1000 LLZ GE HEALTHCARE 717763AI1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1