BEUDAMED
    FDA Adverse Event Death Summary report: N

    4.X INTELLISPACE PACS

    MDR report key: 3674650 · Received February 28, 2014

    Report

    Report Number
    2954704-2014-00001
    Event Type
    Death
    Date Received
    February 28, 2014
    Report Date
    February 5, 2014
    Manufacturer
    PHILIPS HEALTHCARE ENTERPRISE IMAGING INFORMATICS
    Product Code
    LLZ
    PMA / PMN Number
    K111804
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONCE A RADIOLOGIST HAS READ A STUDY, FUNCTIONALITY OF THE DEVICE ALLOWS THE STUDY TO BE MARKED AS "READ". THE CUSTOMER REPORTED THAT THE RADIOLOGIST WAS NOT ABLE TO MARK A PT'S STUDY AS "READ" AFTER PRIMARY INTERPRETATION WAS COMPLETED. THE PT EXPIRED PRIOR TO RADIOLOGIST READING THE STUDY. THE RADIOLOGIST ATTEMPTED TO MARK THE STUDY AS "READ" AFTER THE PT EXPIRED AND COULD NOT ON THE INITIAL ATTEMPT. AS A LATER TIME IN THE DAY, THE RADIOLOGIST WAS ABLE TO MARK THE STUDY AS "READ". THERE IS NO RELATIONSHIP BETWEEN THE TWO OCCURRENCES, PT EXPIRING AND INABILITY TO INITIALLY MARK STUDY AS READ AFTER THE PT EXPIRED. THE CUSTOMER REPORTED THAT DOES NOT APPEAR THAT ISITE CONTRIBUTED TO THE PT'S DEATH. ISITE DID NOT MALFUNCTION. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RADIOLOGIST WAS NOT ABLE TO MARK READ A PT'S STUDY. THE PT EXPIRED PRIOR TO THE RADIOLOGIST READING THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123525 4.X INTELLISPACE PACS LLZ PHILIPS HEALTHCARE ENTERPRISE IMAGING INFORMATICS 835043

    Patients

    Seq Age Sex Outcome Treatment
    1 Death