BEUDAMED
    FDA Adverse Event Death Summary report: N

    PACS HW SERVER

    MDR report key: 5735992 · Received June 20, 2016

    Report

    Report Number
    3004526608-2016-00001
    Event Type
    Death
    Date Received
    June 20, 2016
    Date of Event
    May 21, 2016
    Report Date
    July 27, 2016
    Manufacturer
    GE HEALTHCARE IT
    Product Code
    LLZ
    PMA / PMN Number
    K043415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. MANUFACTURE DATE IS UNKNOWN. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THAT THE MERGING OF TWO PATIENT STUDIES WAS PERFORMED CORRECTLY AND THAT THE STUDY HAD THE APPROPRIATE TIME AND DATE STAMP AFTER THE MERGE. THE INVESTIGATION ALSO REVEALED THAT THE EXAM WAS PRESENT ON THE WORKLIST AND AVAILABLE FOR USE BY THE RADIOLOGIST. THE INVESTIGATION DID NOT IDENTIFY ANY DEFICIENCY WITH THE CPACS PRODUCT. THE CPACS PRODUCT IS WORKING AS DESIGNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PATIENT WAS HOSPITALIZED FOR A SMALL BOWEL OBSTRUCTION AND PAIN. A CT WAS ORDERED FOR THE PATIENT. THE CT SCAN WAS PERFORMED ON (B)(6) 2016. THIS STUDY WAS VIEWED BY RADIOLOGIST ON (B)(6) 2016 WHEN AN EXAM NOTE WAS PERFORMED BY THE RADIOLOGIST THAT INDICATED: SBO WITH FREE AIR AND FLUID. THE WARD DOCTOR WAS NOTIFIED OF THESE FINDINGS ON (B)(6) 2016. THE WARD DOCTOR DETERMINED THAT THE PATIENT WAS TOO FRAIL FOR SURGERY, SO NO SURGERY WAS PERFORMED. THE PATIENT DIED ON (B)(6) 2016. THE FINAL REPORT (SIGNED (B)(6) 2016) INDICATED THAT THERE WAS A DELAY IN READING BECAUSE THE STUDY WAS INCORRECTLY DATE AND TIME STAMPED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390262 PACS HW SERVER SYSTEM, IMAGE PROCESSING, RADIOLOGIC LLZ GE HEALTHCARE IT IAS001

    Patients

    Seq Age Sex Outcome Treatment
    1 Death