BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERNER CARETRACKER

    MDR report key: 3938722 · Received June 12, 2014

    Report

    Report Number
    1931259-2014-00006
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 12, 2014
    Manufacturer
    CERNER CORP.
    Product Code
    OUG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CERNER CONTACTED ALL POTENTIALLY IMPACTED CLIENT SITES ON (B)(4) 2014. EACH CLIENT COMMUNICATION INCLUDED A DESCRIPTION OF THE ISSUE AND NOTIFIES THEM THAT THE SOFTWARE MODIFICATION PREVENTING FUTURE OBSERVATIONS FROM BEING DUPLICATED HAS ALREADY BEEN DEPLOYED. EACH COMMUNICATION ALSO INCLUDES INFORMATION REGARDING RECOVERY ACTIVITIES. CERNER CORPORATION CONSIDERS THIS ISSUE TO BE RESOLVED AND NO FURTHER NARRATIVE IS REQUIRED FOR FOLLOW-UP.

    Description of Event or Problem · 1

    THE ISSUE MAY OCCUR WHEN USING CERNER CARETRACKER ON AN IPAD FOR ENTERING LONG-TERM RESIDENT CARE OBSERVATION DATA. THE SYNCHRONIZATION PROCESS MAY CAUSE ONE OR MORE OBSERVATIONS TO BE DUPLICATED IN THE CARETRACKER DATABASE. WHEN THIS OCCURS, THE DUPLICATE OBSERVATIONS MAY ADVERSELY AFFECT OBSERVATIONAL ALERTS THAT ARE USED FOR ASSESSMENT FOLLOW-UP. CERNER HAS OT RECEIVED COMMUNICATION ON ANY ADVERSE PATIENT EVENTS AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346723 CERNER CARETRACKER SOFTWARE OUG CERNER CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other