BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIS

    MDR report key: 213907 · Received March 10, 1999

    Report

    Report Number
    MW1015877
    Event Type
    Malfunction
    Date Received
    March 10, 1999
    Date of Event
    February 26, 1999
    Report Date
    March 4, 1999
    Manufacturer
    OXFORD INSTRUMENTS - MEDICAL SYSTEMS DIV.
    Product Code
    KXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OXFORD INSTRUMENTS AXIS CENTRAL SYSTEM (OBSTETRICS) FAILS TO ALARM DURING SIGNAL LOSS WITH HEWLETT PACKARD FETAL MONITORS. THE SYSTEM OPERATES PROPERLY WITH OXFORD SONICAID FETAL MONITORS. ON 6/10/98 THERE WAS AN INCIDENT WHERE THE OXFORD FETAL MONITORING NETWORK FAILED TO PRODUCE A SIGNAL LOSS ALARM. THERE WAS NO PT INJURY. OXFORD INSTRUMENTS WAS NOTIFIED AND THE TRACE WAS DOWNLOADED FOR EVALUATION. SUBSEQUENT INVESTIGATION BY THE BIOMEDICAL ENGINEERING DEPT REVEALED THAT NONE OF THE HEWLETT-PACKARD FETAL MONITORS CONNECTED THE NETWORK PRODUCED A SIGNAL LOSS ALARM. THE MONITORS WERE TESTED BY SIMULATING A FETAL HEART RATE OF APPROX 120 BEATS PER MIN AND THEN DISCONTINUING THE SIGNAL. THE PROBLEM WAS REPRODUCIBLE IN EVERY TEST. THE BRADYCARDIA ALARMS WORKED ON THE HEWLETT-PACKARD FETAL MONITORS AND BOTH ALARMS WORKED WHEN THE TEST WAS PERFORMED ON THE MERIDIAN 800 MONITORS. THE TESTS WERE DOCUMENTED AND FAXED TO OXFORD INSTRUMENTS. INITIAL EXPLANATIONS FROM OXFORD WERE INADEQUATE. OXFORD STATED THAT THE LOSS OCCURRED BECAUSE THE 1 MIN CONTINUOUS TRACE CRITERIA WAS NEVER MET. AFTER REEVALUATING THE PT TRACE AND STAFF PROTESTS OXFORD VERBALLY ACKNOWLEDGED THAT THE 1 MIN CRITERIA WAS MET AND THAT THERE WAS A PROBLEM WITH THE LATEST SOFTWARE UPGRADE. (THE PROBLEM OCCURRED SOON AFTER THE SOFTWARE WAS UPGRADED). OXFORD WAS NOTIFIED PERIODICALLY ABOUT THE LACK OF RESOLUTION OF THE PROBLEM BUT NO DATE WAS GIVEN FOR THE PROBLEM TO BE CORRECTED. ON 2/26/99 ANOTHER INCIDENT OCCURRED AT THE HOSP WHERE A SIGNAL LOSS ALARM WAS NOT PRODUCED. FORTUNATELY THERE WAS NO PT INJURY. THE DECISION WAS MADE TO DISCONNECT ALL HEWLETT-PACKARD FETAL MONITORS FROM THE NETWORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIS CENTRAL FETAL MONITORING SYSTEM KXN OXFORD INSTRUMENTS - MEDICAL SYSTEMS DIV. AXIS *

    Patients

    Seq Age Sex Outcome Treatment
    1 *