BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECARECOORDINATOR

    MDR report key: 5247178 · Received November 24, 2015

    Report

    Report Number
    1125873-2015-00026
    Event Type
    Injury
    Date Received
    November 24, 2015
    Date of Event
    October 29, 2015
    Report Date
    December 17, 2015
    Manufacturer
    PHILIPS VISICU
    Product Code
    DRG
    PMA / PMN Number
    K141706
    Removal / Correction Number
    1125873-08-06-15-014-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IDENTIFIED THAT THE ISSUE REPORTED IS ASSOCIATED DEFECT IN WHICH THE DEVICE LOGIC LOOKS BACK 7 DAYS INCLUSIVE OF TODAY AND GETS THE MINIMUM AND THE MAXIMUM VALUE FROM THOSE PAST MEASUREMENTS. THE DEVICE LOGIC THEN COMPARES THE DATE OF THE MAXIMUM AND MINIMUM VALUE TO DETERMINE IF IT IS AN INCREASE OR DECREASE WITHIN THE TIMEFRAME. PATIENT'S WEIGHT MEASUREMENTS RANGED FROM (B)(6). OVER A 7 DAY PERIOD. THE DEVICE ONLY FLAGGED FOR THE WEIGHT LOSS, NOT THE WEIGHT GAIN. THE PATIENT WAS HOSPITALIZED DUE TO THE WEIGHT GAIN. THE INTERVENTION RULE EVALUATES THE DIFFERENCE OF THE LARGEST AND THE SMALLEST VALUE OVER THE DEFINED NUMBER OF DAYS. IF THE CHANGE IN MEASUREMENT MEETS THE REQUIREMENTS, THE INTERVENTION RULE FLAGS. THE DECREASE OF MEASUREMENTS WORKS SIMILARLY, IT EVALUATES THE SMALLEST VALUE AND LARGEST VALUE OVER A NUMBER OF DEFINES DAYS. IF THE CHANGE IN MEASUREMENT MEETS THE REQUIREMENTS AFTER THE SET NUMBER OF DAYS, THE INTERVENTION RULE FLAGS. THE TWO RULES ARE APPLIED SEPARATELY AND AS THE PATIENT EXPERIENCED BOTH LARGER WEIGHT LOSS AND SMALLER WEIGHT GAIN, ONLY THE WEIGHT LOSS MET THE REQUIREMENTS AND THE WEIGHT LOSS WAS FLAGGED. ENGINEERING DEVELOPED A CORRECTIVE ACTION FOR THIS DEFECT AND IS BEING DEPLOYED TO AFFECTED CUSTOMERS. THE DEFECT IS CORRECTED IN V.1.3.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE DEVICE FLAGGED THE PATIENT AS HAVING LOST 4.9 LB IN ONE WEEK. HOWEVER, THE PATIENT ACTUALLY GAINED 5.4LB IN 5 DAYS. PATIENT WAS HOSPITALIZED FOR WEIGHT GAIN DUE TO CONDITION(HEART FAILURE). PATIENT CONDITION IS UNKNOWN.

    Description of Event or Problem · 1

    PHILIPS CLINICAL TEAM WAS INFORMED BY THE CUSTOMER THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER A STAY FROM (B)(6) 2015. PATIENT HAS RETURNED TO THE HOME MONITORING PROGRAM. PATIENT SEEMS TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775457 ECARECOORDINATOR ECARECOORDINATOR DRG PHILIPS VISICU 45356456091

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization