BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECARECOORDINATOR

    MDR report key: 5536459 · Received March 30, 2016

    Report

    Report Number
    1125873-2016-00021
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Date of Event
    March 6, 2016
    Report Date
    May 3, 2016
    Manufacturer
    PHILIPS VISICU
    Product Code
    DRG
    PMA / PMN Number
    K141706
    Removal / Correction Number
    Z-1557-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    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 ECARE COORDINATOR CLINICAL USER INTERFACE. THE CUSTOMER DOES RECEIVE ADHERENCE FLAGS INDICATING THE PATIENT'S MEASUREMENTS HAVE NOT BEEN RECEIVED. ENGINEERING CONTINUES TO INVESTIGATE AND DEVELOP A CORRECTION TO THIS ISSUE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE CORRECTION FOR THE DEFECTS WAS DEVELOPED, TESTED AND RELEASED. PHILIPS IS WORKING WITH CUSTOMERS TO IMPLEMENT THE CORRECTION. THE RECALL NUMBER IS PROVIDED IN CORRECTION NUMBER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY WERE UNABLE TO VIEW THE PATIENT'S MEASUREMENTS (OXIMETRY AND BLOOD PRESSURE) IN THE CLINICAL USER INTERFACE OF THE DEVICE ON THE DATE OF THE INCIDENT. HOWEVER, THE CUSTOMER COULD VIEW THE PATIENT'S 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
    192028 ECARECOORDINATOR ECARECOORDINATOR DRG PHILIPS VISICU 45356456091

    Patients

    Seq Age Sex Outcome Treatment
    1