BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    00275 FCB FSE CBL CORO ROUND

    MDR report key: 615088 · Received June 20, 2005

    Report

    Report Number
    1282497-2005-00013
    Event Type
    Malfunction
    Date Received
    June 20, 2005
    Date of Event
    May 2, 2005
    Report Date
    May 31, 2005
    Manufacturer
    PRECISION INTERCONNECT
    Product Code
    HGP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 05/2005 THAT A CUSTOMER HAD A PROBLEM WITH A SCALPEL ELECTRODE. THE CUSTOMER STATED DECELERATION WAS NOTED ON MONITOR AT 1 1/2 MIN. THE SCALPEL ELECTRODE WAS APPLIED. THE FETAL HEART RATE WAS INITIALLY 60 THEN DROPPED TO 30, TOTAL DECELERATION WITH SCALP ELECTRODE WAS SIX MINUTES. AN EMERGENCY C-SECTION WAS PERFORMED. NO BODY OR NUCHAL CORD WAS NOTED AND NO REASON WAS NOTED FOR THE PROLONGED DECELERATION. APGARS WERE 8/8. AFTER THOUGHT WAS TO CHANGE EXTERNAL CORD BUT TOO MUCH OF AN EMERGENCY AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 00275 FCB FSE CBL CORO ROUND FETAL SCALP ELECTRODE HGP PRECISION INTERCONNECT UNK R28274

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other