BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECARECOORDINATOR

    MDR report key: 5091656 · Received September 21, 2015

    Report

    Report Number
    1125873-2015-00016
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    August 24, 2015
    Report Date
    November 6, 2015
    Manufacturer
    PHILIPS VISICU
    Product Code
    DRG
    PMA / PMN Number
    K141706
    Removal / Correction Number
    1125873-08-24-15-019-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING HAS DEVELOPED A CORRECTIVE ACTION ASSOCIATED WITH THIS ISSUE. THE CORRECTIVE ACTION IS BEING DEPLOYED TO THE AFFECTED CUSTOMERS.

    Additional Manufacturer Narrative · 1

    INITIAL INVESTIGATION IN THE EVENT IDENTIFIED THE FOLLOWING: THE PATIENT WAS ONLY TAKING WEIGHT MEASUREMENTS ONCE A WEEK. WEEK 1, THE PATIENT SUBMITTED A WEIGHT MEASUREMENT OF (B)(6) AND ON THE SECOND WEEK (7 DAYS LATER) THE PATIENT SUBMITTED A WEIGHT MEASUREMENT OF (B)(6) AND NO FLAG WAS GENERATED. THE PATIENT DID NOT SUFFER FROM SERIOUS INJURY NOR WAS INTERVENTION TAKEN. THE PATIENT HAD 8 RULES CONFIGURED BY THE HEALTH FACILITY FOR THE THEM. ONLY ONE RULE LOOKED FOR WEIGHT INCREASE OF THAT NUMBER OF DAYS: RULE 4: IF THE MAXIMUM CHANGE OVER THE LAST 8 DAYS HAS INCREASED BY MORE THAN 7.9 LBS THEN SET A FLAG OF HIGH SEVERITY. INVESTIGATION DETERMINED THAT THE WEIGHT GAIN DID NOT FLAG DUE TO THE REQUIREMENT THAT STATES "IF THE X NUMBER OF DAYS SPECIFIED IN THE INTERVENTION RULE EXISTS FROM THE CURRENT EPISODE START DATE TO TODAY, EVALUATE THE MEASUREMENT". AS THERE WERE ONLY 7 DAYS ON THE EPISODE AND THE INTERVENTION RULE TRIGGERS AT 8, THE MEASUREMENT DID NOT FLAG.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO PHILIPS VISICU THAT THE PATIENT WEIGHT VALUES ARE OUTSIDE TRIGGER BOUNDS BUT THE WEIGHT CHANGE WAS NOT TRIGGERED/FLAGGED. THE PATIENT DID NOT SUFFER FROM SERIOUS INJURY NOR WAS INTERVENTION TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622588 ECARECOORDINATOR ECARECOORDINATOR DRG PHILIPS VISICU 453564506091

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability