BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECARECOORDINATOR

    MDR report key: 6028657 · Received October 13, 2016

    Report

    Report Number
    1125873-2016-00042
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Report Date
    October 5, 2016
    Manufacturer
    VISICU, INC
    Product Code
    DRG
    PMA / PMN Number
    K141706
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PHILIPS Q&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. THIS ISSUE OCCURS IF YOU HAVE A PATIENT WHOSE INTERVENTION RULES EXPIRE AND, WHILE WAITING FOR HE TIME BASED ACTION TO EXECUTE, IF THE PATIENT RECORD IS UPDATED THEN THE PATIENT RECORD IS REMOVED FROM THE TIME-BASE WORKFLOW QUEUE. THIS CAUSES THE LAST INTERVENTION EXPIRED FIELD NOT TO GET UPDATES ON THE PATIENT AND SINCE THAT FIELD IS NOT SET ON THE PATIENT RECORD THEN THE CHECK PATIENT CALENDAR TASK IS NOT GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677450 ECARECOORDINATOR ECARECOORDINATOR DRG VISICU, INC 453564506091

    Patients

    Seq Age Sex Outcome Treatment
    1