BEUDAMED
    FDA Adverse Event Death Summary report: N

    PACS SERVER

    MDR report key: 1651198 · Received April 2, 2010

    Report

    Report Number
    3004526608-2010-00006
    Event Type
    Death
    Date Received
    April 2, 2010
    Date of Event
    February 27, 2010
    Report Date
    March 5, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K043415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    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 REPORTED THAT THE TECHNICIAN ENTERED THE DATE OF BIRTH (B) (6) INSTEAD OF THE STUDY DATE OF (B) (6), MAKING THE REPORT APPEAR OLDER THAN WHAT IT WAS. THE RADIOLOGIST WAS VIEWING THE IMAGES FOR PIC LINE PLACEMENT AND THE COMPARISON FILM DID NOT HAVE THE LINE PRESENT. WHEN THE FILM DID NOT HAVE THE LINE PRESENT, THE RADIOLOGIST ASSUMED THE LINE HAD BEEN REMOVED, NOT VERIFYING PROPER PLACEMENT. THE BABY, WHO WAS PRE-MATURE, DIED. THE RISK MANAGER STATED THAT THE LINE WAS INSERTED TOO FAR, WHICH CONTRIBUTED TO THE DEATH, THOUGH NOT CERTAIN IT CAUSED THE DEATH. THE RISK MANAGER ALSO STATED THAT THEY CONSIDER THE INCIDENT A "WORK PROCESS ERROR" AND NOT A MALFUNCTION OF PACS.

    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 4 DA Death