BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECARECOORDINATOR

    MDR report key: 5491724 · Received March 10, 2016

    Report

    Report Number
    1125873-2016-00002
    Event Type
    Malfunction
    Date Received
    March 10, 2016
    Date of Event
    February 16, 2016
    Report Date
    April 12, 2016
    Manufacturer
    PHILIPS VISICU
    Product Code
    DRG
    PMA / PMN Number
    K141706
    Removal / Correction Number
    1125873-04-01-2016-009-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. SECTIONS CONTAIN ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION. A CORRECTION TO THE SOFTWARE DEFECT HAS BEEN DEVELOPED AND WILL BE IMPLEMENTED WITH CUSTOMERS.

    Additional Manufacturer Narrative · 1

    ENGINEERING INVESTIGATED THIS ISSUE THROUGH CODE REVIEW AND PATIENT DATA; AND DETERMINED THAT IT IS ASSOCIATED WITH A SOFTWARE DEFECT. WHEN THE SOFTWARE DEFECT OCCURS, THE PATIENT'S SUBMITTED MEASUREMENTS ARE NOT POPULATED IN THE PATIENT'S DATA TABLE. THE CLINICIAN IS UNABLE TO VIEW THE PATIENT'S MEASUREMENTS IN THE ECARECOORDINATOR CLINICAL USER INTERFACE. THE CLINICIAN WILL NOT RECEIVE ANY FLAGS TO INDICATE THAT THE MEASUREMENTS WERE NOT PROCESS CORRECTLY, AND INTERVENTION RULES WILL NOT BE PROPERLY APPLIED. ENGINEERING CONTINUES TO INVESTIGATE AND DEVELOP A CORRECTION TO THIS ISSUE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. SECTIONS CONTAINS INFORMATION REGARDING THE CORRECTIVE ACTION. A CORRECTION TO THE SOFTWARE DEFECT HAS BEEN DEVELOPED AND WILL BE IMPLEMENTED WITH CUSTOMERS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY WERE UNABLE TO VIEW THE PATIENT'S MEASUREMENTS IN THE CLINICAL USER INTERFACE OF THE DEVICE. HOWEVER, THE CUSTOMER COULD VIEW THE PATIENTS MEASUREMENTS WITH A BACK END TOOL. THE CUSTOMER DID NOT REPORT ANY CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147751 ECARECOORDINATOR ECARECOORDINATOR DRG PHILIPS VISICU 45356456091

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR