BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES IV PHYSIO-MONITORING SYSTEM

    MDR report key: 1195499 · Received October 13, 2008

    Report

    Report Number
    1039368-2008-00002
    Event Type
    Injury
    Date Received
    October 13, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 13, 2008
    Manufacturer
    WITT BIOMEDICAL CORP, A WHOLLY OWNED SUBSIDARY OF PHILLIPS HOLDING USA INC.
    Product Code
    MWI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO CUSTOMER SITE. SEE INVESTIGATION RESULTS. REVIEW OF LABELING WAS PERFORMED. THE CS IS A NETWORKED DEVICE & CAN LOSE COMMUNICATION WITH THE PCM. BECAUSE OF THIS, THE PCM SHOULD BE THE MAIN MONITORING DEVICE, AND SHOULD ALWAYS USE ALARMS PER IFU (INSTRUCTIONS FOR USE) PCM USER'S GUIDE, REV 9, PAGE XIX, #36 STATES THAT "CALYSTO MONITORS PHYSIOLOGIC PARAMETERS AND PROVIDES VISUAL AND AUDIBLE ALARMS. IT IS NOT DESIGNED FOR UNATTENDED USE. ALARMS MAY BE ACTIVATED OR DEACTIVATED AT THE USER'S DISCRETION AND IT'S THE USER'S RESPONSIBILITY TO CONFIGURE AND ACTIVATE THE ALARMS FOR EACH PT." PAGE XXI, STATES "USE OF CALYSTO CENTRAL STATION AND PT CARE MONITORS IS NOT INTENDED WHERE UNATTENDED PT MONITORING IS DESIRED, OR IN SITUATIONS WHERE ARRHYTHMIA DETECTION IS REQUIRED." ALTHOUGH THE PT WENT INTO VT, THE SYSTEM FUNCTIONED AS INTENDED, THERE WAS NO DETERIORATION IN EFFECTIVENESS OF THE DEVICE AND THERE WAS NOT AN INADEQUACY IN THE LABELING OR IFU'S. THE SYSTEM WAS MONITORING THE PT VITALS BUT THE SYSTEM DID NOT ALARM BECAUSE THE CUSTOMER HAD CHOSEN TO DEACTIVATE ALL ALARMS, WINDOWS VOLUMES AND SOUND CARD VOLUMES ON THE PCMS AND CSS. IT IS IMPOSSIBLE TO RESTRICT THE USER FROM DEACTIVATING THE ALARMS, BECAUSE THE PT MAY NEED TO BE DISCONNECTED FROM THE SYSTEM TO WALK OR GO TO THE BATHROOM. THE CUSTOMER IS MEETING TO DISCUSS HOW TO PREVENT FUTURE OCCURRENCES. CONCLUSIONS: USE ERROR: CUSTOMER CHOSE TO DEACTIVATE ALL ALARMS, WINDOWS VOLUME AND SOUND CARD VOLUMES ON ALL PCMS AND CSS AGAINST IFU RECOMMENDATIONS. THE USER NOR THE DEVICE CAUSED THE PT TO GO INTO VT, BUT IF THE ALARMS HAD BEEN ACTIVATED, THERE WOULD HAVE BEEN A MORE TIMELY RESPONSE.

    Description of Event or Problem · 1

    CUSTOMER CALLED AND STATED THAT THEIR PT WENT INTO VENTRICULAR TACHYCARDIA (VT) WHILE BEING MONITORED ON A PT CARE MONITOR (PCM), AND CENTRAL STATION (CS). THEY STATED THAT THE CS DID NOT DISPLAY THE WAVEFORMS, SO THEY WERE NOT AWARE THAT THE PT WENT INTO VT UNTIL THEY WENT INTO THE ROOM TO CHECK ON THE PT. THE NURSE STATED THAT THE ALARMS DID NOT ALARM DURING THIS EVENT. THE PT CODED, WAS SUCCESSFULLY RESUSCITATED, AND MOVED TO ICU. OUR FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO INVESTIGATE, AND FOUND THAT THE PCM AND CS ALARMS WERE SET, BUT HAD BEEN DEACTIVATED ON ALL PCMS AND THE CS. THE FSE ALSO NOTED THAT THE WINDOWS VOLUME AND SOUND CARD VOLUME WERE MUTED ON ALL PCMS AND THE CS. THIS IS NOT THE NORMAL SET UP. THE FSE ENABLED THE ALARMS AND TESTED COMMUNICATIONS BETWEEN THE PCMS AND THE CS, AND VERIFIED THAT THE ALARMS SOUNDED ON THE CS, WAVEFORMS WERE PRESENT AND THE PCMS WERE CORRECTLY IDENTIFIED ON THE NETWORK. THE FSE ALSO IN-SERVICED THE STAFF ON BASIC ALARM FUNCTIONALITY FOR PCMS AND CSS. THE FSE CONCLUDED THAT THE SYSTEM WAS BEING USED IN A CAPACITY FOR WHICH IT WAS NOT DESIGNED, SPECIFICALLY, THEY HAD DEACTIVATED ALL ALARMS. THIS WAS A CONCERN, BECAUSE THE PCMS WERE BEHIND CLOSED DOORS AND THE CS WAS NOT IN THE IMMEDIATE AREA OF THE PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES IV PHYSIO-MONITORING SYSTEM SERIES IV CENTRAL STATION MWI WITT BIOMEDICAL CORP, A WHOLLY OWNED SUBSIDARY OF PHILLIPS HOLDING USA INC. CENTRAL STATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening SERIES IV PT CARE MONITOR| CATALOG # FCV4549