BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTELLIVUE, VIRIDIA

    MDR report key: 557050 · Received November 2, 2004

    Report

    Report Number
    557050
    Event Type
    Other
    Date Received
    November 2, 2004
    Date of Event
    August 14, 2004
    Report Date
    September 10, 2004
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    DRT
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    IN AN INTERMEDIATE CRITICAL CARE UNIT, A PATIENT REMOVED THE TELEMETRY TRANSMITTER LEADWIRES. SHORTLY THEREAFTER, OR SLIGHTLY PRIOR, THE PATIENT EXITED THE BED. LATER THAT EVENING, A STAFF MEMBER FOUND THE PATIENT LYING ON THE FLOOR NEXT TO THE BED. THE PATIENT WAS UNRESPONSIVE AND A CODE WAS CALLED. ATTEMPTS TO RESUSCITATE THE PATIENT WERE UNSUCCESSFUL. A PHILIPS VIRIDIA TELEMETRY SYSTEM WAS EMPLOYED, WITH INTELLIVUE CENTRAL MONITORING EQUIPMENT, AUGMENTED WITH A PHILIPS DATABASE SERVER AND A STATVIEW PAGING SYSTEM, RUNNING UNDER SOFTWARE VERSION E. AN UPGRADE FROM VERSION D TO E OCCURRED A FEW WEEKS PRIOR. A COPY OF THE PATIENT ALARM FILE TAKEN FROM THE ASSOCIATED PHILIPS PATIENT INFORMATION CENTER WAS E-MAILED TO PHILIPS MEDICAL FOR DECRYPTING AND DECODING. THE SUBSEQUENT REPORT FROM PHILIPS INDICATED NO RED OR YELLOW ALARMS GENERATED FOR THE BED IN QUESTION FOR THE ENTIRE DAY OF THE EVENT. SINCE ALL INOP ALARMS TO STATVIEW PAGERS WERE INTENTIONALLY DISABLED BY THE CUSTOMER IN 2002 DUE TO A KNOWN DEFECT IN VERSION D (EXCESSIVE PAGING OF INOP ALARMS), AND THIS DEFAULT VALUE WAS INHERITED DURING THE SOFTWARE UPGRADE TO VERSION E, NO INOP ALARMS WERE SENT TO STATVIEW PAGERS. A REVIEW OF THE PAGING LOG IN THE DATABASE SERVER REVEALED NO INOP ALARMS WERE RECORDED (UNLIKE VERSION D, WHICH RECORDED ALL INOP ALARMS, REGARDLESS OF STATVIEW SETTINGS). THEREFORE, NO CONFIRMATION CAN BE MADE OF THE LEADS OFF ALARM, ITS DURATION, OR IF THE ALARM WAS MANUALLY SILENCED. IT IS NOT BELIEVED THAT THE DEVICE NECESSARILY CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE, VIRIDIA TELEMETRY MONITORING SYSTEM DRT PHILIPS MEDICAL SYSTEMS, INC. M3150 N/A
    2 STATVIEW PAGING SYSTEM ALARM SYSTEM, PATIENT MONITORING DRT GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR