BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROMETRICS QWIKCONNECT PLUS SPIRAL ELECTRODE

    MDR report key: 1844650 · Received September 23, 2010

    Report

    Report Number
    9613557-2010-00007
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 12, 2010
    Report Date
    September 23, 2010
    Manufacturer
    GE HEALTH
    Product Code
    HGP
    PMA / PMN Number
    K792669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTEDLY DISCARDED THE FETAL SCALP ELECTRODE, THEREFORE, THE DEVICE IS UNAVAILABLE FOR INVESTIGATION. SUBSEQUENT ATTEMPTS TO COLLECT INFO AND F/U WITH THE CUSTOMER WERE UNSUCCESSFUL. GE HEALTHCARE PROVIDED THE CUSTOMER WITH A REFERENCE GUIDE ENTITLED ":APPLICATION OF THE COROMETRICS QWIK CONNECT PLUS SPIRAL ELECTRODE." THE REFERENCE GUIDE IS INCLUDED WITH THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN INFANT INCURRED A LACERATION DURING REMOVAL OF THE FETAL SCALP ELECTRODE. THE NURSE REPORTEDLY PLACED THE FETAL SCALP ELECTRODE WHILE THE MOTHER WAS IN LABOR, DUE TO DIFFICULTY PICKING UP FETAL TONES. THE FETAL SCALP ELECTRODE PLACED BY THE NURSE REPORTEDLY FELL OFF AND THE DOCTOR PLACED A SECOND FETAL SCALP ELECTRODE. THE MOTHER WAS TAKEN TO THE OPERATING ROOM FOR AN IMMEDIATE CAESAREAN SECTION DUE TO SUBSEQUENT DECREASED FETAL HEART RATE WHILE PUSHING. A NURSE REPORTEDLY REMOVED THE FETAL SCALP ELECTRODE VAGINALLY PRIOR TO THE CAESAREAN SECTION. IT IS UNK WHETHER THE SAME NURSE THAT PLACED THE FETAL SCALP ELECTRODE REMOVED THE DEVICE. AFTERWARD, A PEDIATRICIAN NOTED A SUPERFICIAL LACERATION SIMILAR TO A LACERATION EXPERIENCED BY A SURGICAL CUT DURING A CAESAREAN SECTION. THE LACERATION WAS LOCATED ON THE POSTERIOR PORTION OF THE HEAD, NOT MIDLINE. TWO SUTURES WERE REPORTEDLY PLACED DUE TO CAPUT AND OOZING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROMETRICS QWIKCONNECT PLUS SPIRAL ELECTRODE FETAL SCALP SPIRAL ELECTRODE HGP GE HEALTH S30091

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other