BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYSTIC

    MDR report key: 584949 · Received March 25, 2005

    Report

    Report Number
    1216677-2005-00007
    Event Type
    Death
    Date Received
    March 25, 2005
    Date of Event
    February 20, 2005
    Report Date
    March 24, 2005
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HDB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PREGNANT PT PRESENTED AT 33 1/7 WEEKS GESTATION AND HAVING THREE OUTPATIENT VISITS PRIOR TO ADMISSION. THE PT PRESENTED WITH SPONTANEOUS RUPTURE OF MEMBRANES AND PROGRESSES IN LABOR TO A POINT OF EXTREME DISCOMFORT AND DESIRE TO PUSH. THE FETAL HEART TONES WERE WITHIN NORMAL LIMITS THROUGHOUT LABOR. AN ATTEMPT WAS MADE TO DELIVER VAGINALLY, COMPLICATED BY A DECREASE IN FETAL HEART TONES DOWN TO THE 70'S. OXYGEN WAS APPLIED 10 LITERS PER MINUTE BY MASK. THE PT WAS PUSHING, BUT THE BABY WAS NOT MOVING DOWN INTO THE BIRTH CANAL. OB-GYN PHYSICIAN REQUESTED A VACUUM EXTRACTOR. IT IS UNCERTAIN IF A MYSTIC M-STYLE PHYSICIAN-HELD EXTRACTOR WAS ATTEMPTED. PHYSICIAN REQUESTED THE MYSTIC INSTYLE EXTRACTOR. TWO ATTEMPTS WERE MADE TO OBTAIN A SEAL AT 50 CM HG WITH TWO POP OFFS. PHYSICIAN WAS UNABLE TO OBTAIN AN ADEQUATE SEAL. THE PT WAS DELIVERED BY EMERGENCY C-SECTION WITH APGARS OF 2-7-9. THE C-SECTION DELIVERY WAS COMPLICATED BY THE HEAD BEING TIGHTLY WEDGED IN THE BIRTH CANAL. PHYSICIAN REQUIRED ASSISTANCE IN MANUALLY PUSHING THE FETAL HEAD UP INTO THE UTERINE CAVITY FOR DELIVERY. POST DELIVERY, THE INFANT WAS DIAGNOSED WITH MULTIPLE CEREBELLAR HEMORRHAGES AND SUBALIAL AND CEPHALOHEMATOMAS. THE PT WAS REMOVED FROM THE VENTILATOR AT 12 DAYS OF AGE AND EXPIRED THE FOLLOWING DAY." REFERENCE MEDWATCH 0503530000-2005-8001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYSTIC VACUUM ASSISTED DELIVERY SYSTEM HDB COOPERSURGICAL, INC. 10047 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death| R