BEUDAMED
    FDA Adverse Event Death Summary report: N

    KOALA

    MDR report key: 1612044 · Received January 29, 2010

    Report

    Report Number
    1612044
    Event Type
    Death
    Date Received
    January 29, 2010
    Date of Event
    December 26, 2009
    Report Date
    January 27, 2010
    Manufacturer
    CLINICAL INNOVATIONS LLC.
    Product Code
    HFN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B) (6) GESTATION CAME FOR SPONTANEOUS LABOR AT 2:26 AM. LABOR PROGRESSED NORMALLY UNTIL 10:23 AM. AT 10:18 AM, AN INTRAUTERINE PRESSURE CATHETER (IUPC) WAS INSERTED. AT 10:23 AM THE FETUS EXPERIENCED A PROLONGED DECELERATION WITH FETAL HEART RATES (FHR) DROPPING TO THE 70'S. INTRAUTERINE RESUSCITATION EFFORTS WERE INITIATED. IN SPITE OF EFFORTS, THE FETUS CONTINUED TO DETERIORATE, A STAT C-SECTION WAS PERFORMED AND THE FETUS WAS BORN WITHOUT ANY SIGNS OF LIFE. ATTEMPTS TO RESUSCITATE THE BABY WERE UNSUCCESSFUL. THIS WAS AN UNUSUAL EVENT AND AN EXTENSIVE INVESTIGATION HAS BEEN CONDUCTED OVER THE PAST 30 DAYS. WE HAVE BEEN UNABLE TO DETERMINE THE CAUSE OF DEMISE FOR THIS BABY. IT WAS NOT ORIGINALLY THOUGHT TO BE RELATED TO THE IUPC AS THE IUPC WENT IN EASILY AND CLEAR FLUID WAS RETURNED. THE STAFF DID NOT SAVE THE IUPC BECAUSE THEY DID NOT BELIEVE IT HAD ANYTHING TO DO WITH THE DEMISE. WE HAVE NO EVIDENCE THAT IT WAS RELATED TO THE IUPC. WE ARE REPORTING BECAUSE THE TIMING OF INSERTION OF THE IUPC AND THE DETERIORATION OF FHR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOALA NONE HFN CLINICAL INNOVATIONS LLC. 451739

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Death STAFF DID NOT SAVE THE DEVICE