BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECARECOORDINATOR

    MDR report key: 6030456 · Received October 14, 2016

    Report

    Report Number
    1125873-2016-00043
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Report Date
    October 14, 2016
    Manufacturer
    VISICU, INC
    Product Code
    DRG
    PMA / PMN Number
    K141706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS Q AND R HAS COMPLETED THE INVESTIGATION FOR THE REPORTED FAILURE OF PROTOCOLS ENDING WITHOUT NOTICE (RNS ARE UNAWARE) WITH THE ECARE COMPANION HOME TELEMONITORING SYSTEM. THIS COMPLAINT HAS BEEN CONFIRMED AND A FIX WAS IMPLEMENTED VIA FCO 1125873-10-06-16-017-C IN SOFTWARE VERSION 1.4.0.5. Q&R WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IF A PATIENT GENERATES AN ADHERENCE FLAG ON THE FINAL DAY OF THE PATIENT'S IR, THE PATIENT'S INTERVENTION EXPIRED FIELD IS NOT BEING SET, AND NO CHECK PATIENT CALENDAR TASK WILL BE GENERATED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680878 ECARECOORDINATOR ECARECOORDINATOR DRG VISICU, INC 453564506091

    Patients

    Seq Age Sex Outcome Treatment
    1