BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MEDICAL SYSTEMS MRX

    MDR report key: 562531 · Received December 2, 2004

    Report

    Report Number
    MW1033971
    Event Type
    Malfunction
    Date Received
    December 2, 2004
    Report Date
    December 2, 2004
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HOSP PURCHASED 60 PHILIPS MONITOR/DEFIBRILLATORS IN TWO PROCUREMENTS, WITH TWO MONITOR/DEFIBRILLATORS COMING IN OUT OF CYCLE. EIGHT OF THE UNITS WERE PLACED IN SVC IN LATE MARCH IN THE CATH LAB. THE OTHER 6 UNITS WERE HELD FOR BACKUP AND WERE PLACED IN SVC WITH THE SECOND PROCUREMENT OF MONITOR/DEFIBRILLATORS WHICH TOOK PLACE IN 6/04 AFTER THE STAFF RECEIVED TRAINING AND IN SERVICE ON THE NEW EQUIPMENT. PROBLEM INDICATOR: ON THE FRONT, TOP, RIGHT HAND SIDE, OF THE MONITOR/DEFIBRILLATOR IS AN LCD. THIS LCD DISPLAYS AN HOURGLASS ICON FOR NORMAL OPERATION AND A RED "X" WHEN THE SELF CHECK DISCOVERS AN ERROR. EVENTS AND PROBLEM: ALMOST IMMEDIATELY AFTER DEPLOYMENT THE CLINICAL ENGINEERING DEPT STARTED RECEIVING TROUBLE CALLS ON UNITS WITH RED X'S. THE C.E. DEPT WOULD PERFORM THE SOFTWARE DRIVEN OPERATIONAL CHECKOUT PROCEDURE TO FIND WHERE THE UNIT FAILED AND THIS PROCEDURE WOULD CLEAR THE RED X AND RETURN THE UNIT TO NORMAL OPERATION. IN THE BEGINNING DEDUCED THE RED X TO BE CAUSED BY OPERATOR ERROR. HOWEVER; IT SOON BECAME EVIDENT THAT THERE WAS MORE GOING ON THAN OPERATOR ERROR AND STARTED TO DOCUMENT EACH OCCURRENCE. NEXT STEP WAS TO NOTIFY PHILIPS EACH TIME THEY HAD A RED X FAILURE. THE PHILIPS SVC SUPPORT CENTER GIVE HOSP THE PASSWORD TO ENTER THE SVC PORTION OF THE SOFTWARE AND THAT'S WHEN HOSP FOUND OUT, FOR SURE, THAT HOSP HAD EQUIPMENT AND NOT OPERATOR PROBLEMS. SPREAD SHEETS: BETWEEN 6/04 AND 11/04 THE CLINICAL ENGINEERING DEPT HAS DOCUMENTED 50 RED X ERRORS ON 32 DIFFERENT PHILIPS MONITOR/DEFIBRILLATORS. THIS IS SLIGHTLY OVER A 50% FAILURE RATE IN ROUGHLY 4 1/2 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEMS MRX MONITOR/DEFIBRILLATOR LDD PHILIPS MEDICAL SYSTEMS M3535A *

    Patients

    Seq Age Sex Outcome Treatment
    1 *