BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECARECOORDINATOR

    MDR report key: 5506288 · Received March 16, 2016

    Report

    Report Number
    1125873-2016-00015
    Event Type
    Malfunction
    Date Received
    March 16, 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

    IT IS NOTED THAT THIS ADVERSE EVENT REPORT WAS SPLIT FROM MDR 1125873-2016-0002 AS IT WAS IDENTIFIED THAT THERE WERE TWO OCCURENCES OF THE SAME DEFECT. THE EVENT THAT IS ADDRESSED IN THIS ADVERSE EVENT REPORT OCCURRED ON (B)(6) 2016 AND THE MEASUREMENTS WERE BLOOD PRESSURE AND SPO2. 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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION.

    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 FOR (B)(6) 2016. HOWEVER, THE CUSTOMER COULD VIEW THE PATIENTS MEASUREMENTS WITH A BACK END TOOL. THE CUSTOMER DID NOT REPORT ANY CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159311 ECARECOORDINATOR ECARECOORDINATOR DRG PHILIPS VISICU 45356456091

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR