BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACS SERVER

    MDR report key: 1834537 · Received September 9, 2010

    Report

    Report Number
    3004526608-2010-00027
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 11, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K043415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT IN VASCULAR SPECIALTIES (XA) IMAGES AND IN FLUOROSCOPY (RF) IMAGES THE SCALE OF THE RULER IS NOT ACCURATE. THE SCALE SHOWS 5 CM WHICH DOESN'T CORRESPOND WITH THE REAL DISTANCE. IF THE CUSTOMER DID THE SAME MEASUREMENTS ON THE MODALITY AND ON THE PACS, THEY RECEIVE DIFFERENT RESULTS. THERE WAS NO REPORTED PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACS SERVER LLZ GE HEALTHCARE UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1