BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECARECOORDINATOR

    MDR report key: 6263525 · Received January 19, 2017

    Report

    Report Number
    1125873-2017-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2017
    Report Date
    January 4, 2017
    Manufacturer
    VISICU, INC - DUP
    Product Code
    DRG
    PMA / PMN Number
    K141706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS Q&R HAS COMPLETED THE INVESTIGATION FOR THE REPORTED FAILURE OF MULTIPLE PATIENT SURVEYS RECEIVED AND UNABLE TO CLEAR FLAGS WITH THE ECARE COMPANION HOME TELEMONITORING SYSTEM. THIS COMPLAINT HAS BEEN CONFIRMED. THE MESSAGE BROKER LOGIC RELIES ON A YEAR COMPARISON INSTEAD OF A DATE COMPARISON TO DETERMINE IF A SURVEY HAS ALREADY BEEN SCHEDULED. WHEN THE YEAR CHANGED FROM 2016 TO 2017, THE LOGIC CONTINUOUSLY FAILED UNTIL ALL SURVEYS STILL PENDING WITH THE YEAR 2016 WERE RESOLVED. AN ENHANCEMENT WILL BE IMPLEMENTED IN VERSION 1.5.4.2 SB TO PREVENT THE LOGIC FROM FAILING IN THIS MANNER IN FUTURE YEAR CHANGES. QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    CUSTOMER STATED HER PT ARE RECEIVING MULTIPLE SURVEYS AND SHE IS UNABLE TO CLEAR THE FLAGS. PER CUSTOMER: ALL PATIENTS THAT ANSWER THEIR SURVEY HAS THE EXACT SAME THIS SHOW UP MOMENTS LATER EXCEPT ONLY THE FIRST ONE HAS THEIR NAME ATTACHED TO IT. IT REPEATS UNLESS THEN JUST DO NOT ANSWER IT. WHEN I TRY TO ACKNOWLEDGE THE FLAG FOR THE SURVEY IT WILL NOT OPEN THE NOTE TO LET ME TYPE ANYTHING. I WENT BACK IN AND CHARTED MORE THIS IS THE MESSAGE THAT CAME UP WHEN I HAD CHECKED THE ALERTS; INCLUDING THE SURVEY SCORE ALERT, THEN CLICKED THE ACKNOWLEDGE BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46573 ECARECOORDINATOR ECARECOORDINATOR DRG VISICU, INC - DUP 453564506091

    Patients

    Seq Age Sex Outcome Treatment
    1