BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 316015 · Received February 9, 2001

    Report

    Report Number
    MW1021055
    Event Type
    Malfunction
    Date Received
    February 9, 2001
    Date of Event
    January 4, 2001
    Report Date
    February 7, 2001
    Manufacturer
    AGILENT TECHNOLOGIES
    Product Code
    KXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 3/20/01: IN 12/00, AGILENT INITIATED A VOLUNTARY RECALL FOR THE SAFECONNECT DECG ADAPTER MODEL M1347A AFTER RECEIVING REPORTS OF LOSS OF DECG SIGNAL, WHICH MAY HAVE BEEN DUE TO POOR ELECTRICAL CONNECTION MAY CAUSE LOSS OF OR INTERFERENCE WITH THE DECG SIGNAL. AGILENT NOTIFIED THE FOOD AND DRUG ADMINISTRATION OF THIS RECALL ON 12/8/01. AGILENT HAS NOT YET RECEIVED NOTICE THAT THE RECALL HAS BEEN CLASSIFIED BY CDRH OR ASSIGNED A Z NUMBER. THE SAFECONNECT DECG ADAPTER MODEL M1347A WAS MODIFIED BY INCREASING THE SPACING BETWEEN THE ADAPTER CONTACTS SO THAT THEY PRESS MORE TIGHTLY AGAINST THE CONTACTS OF THE MATING PART ON THE LEG PLATE, AND BY ADDING A LENGTHWISE BEND TO THE ADAPTER CONTACTS SO THAT TWO SHARP EDGES ARE PRESENTED TO THE MATING PART RATHER A LARGE FLAT SURFACE.

    Description of Event or Problem · 1

    THERE WERE PROBLEMS WITH THE USE OF THE CABLE AND ADAPTER USED WITH FETAL SCALP ELECTRODES - EITHER INTERMITTENT OR ABSENT SIGNALS. PT'S FETAL HEART TONES WERE INTERMITTENT AND ABSENT THROUGHOUT THE MONITORING PROCESS. SINCE THIS EVENT, THE CO SUPPLIED AN EQUIPMENT UPGRADE AS THIS HOSP WAS NOT INCLUDED IN THE RECALL PROCESS. (THE HOSP WAS USING THE EQUIPMENT NOT KNOWING THERE WAS A PROBLEM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5014 * FETAL MONITORING/SCALP ELECTRODE KXN AGILENT TECHNOLOGIES ADAPTER M1347A *
    5015 * FETAL MONITORING/SCALP ELECTRODE HGP AGILENT TECHNOLOGIES MONITOR 1350B *

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR