BEUDAMED
    FDA Adverse Event Death Summary report: N

    COROMETRICS MONITOR

    MDR report key: 3369763 · Received September 18, 2013

    Report

    Report Number
    9617277-2013-00001
    Event Type
    Death
    Date Received
    September 18, 2013
    Date of Event
    August 5, 2012
    Report Date
    August 20, 2013
    Manufacturer
    WIPRO GE HEALTHCARE PRIVATE LTD
    Product Code
    HGM
    PMA / PMN Number
    K072976
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEGAL COMPLAINT THAT GENERAL ELECTRIC COMPANY RECEIVED ALLEGES THE FOLLOWING: "THE COROMETRICS MONITOR MADE IT APPEAR TO THE HEALTHCARE PROVIDERS THAT THE FETAL HEART RATE WAS BEING MONITORED THROUGHOUT LABOR AND WAS NORMAL." "HOWEVER, AT SOME POINT HOURS BEFORE DELIVERY, HIS FETAL HEART RATE BECAME DISTRESSED. INSTEAD OF PICKING UP THIS DISTRESS, THE COROMETRICS FETAL HEART MONITOR MADE A SMOOTH TRANSITION TO THE MATERNAL HEART RATE, CONFUSING THE HEALTHCARE PROVIDERS INTO BELIEVING THE BABY'S HEART WAS FINE." GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    NO INFORMATION HAS BEEN PROVIDED TO GE HEALTHCARE BY THE HOSPITAL ON THE STATUS OF THE UNIT. AT THIS TIME, IT IS NOT KNOWN IF THE UNIT WAS TAKEN OUT OF SERVICE OR IF IT CONTINUES TO BE USED WITH PATIENTS. NO FURTHER DETAILS ABOUT THE ALLEGED DEVICE OR THE EVENT HAVE BEEN PROVIDED TO GE HEALTHCARE. THERE ARE NO SERVICE RECORDS FOR THE DEVICE IN THE GE HEALTHCARE DATABASE. THEREFORE, WITHOUT SUFFICIENT INFORMATION ABOUT THE EVENT, OR THE EVALUATION OF THE ALLEGED DEVICE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE ALLEGED ISSUE.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION WAS OBTAINED BY GE HEALTHCARE THROUGH THE LEGAL PROCEEDINGS RELATED TO THIS CASE. MULTIPLE CLINICAL SIGNS PRESENTED THAT INDICATED FETAL DISTRESS DURING THE MONITORING SESSION TO WHICH THE OB TEAM DID NOT TAKE APPROPRIATE ACTIONS: LOW FETAL HEART RATE VARIABILITY- A HEALTHY FETUS HAS HIGH HEART RATE VARIABILITY. MATERNAL HEART RATE WAS VERY CLOSE TO FETAL HEART RATE; THE STRIP CHART INDICATED THE MATERNAL HEART RATE AND FETAL HEART RATE ACTUALLY OVERLAPPED 5 TIMES DURING THE MONITORING SESSION, AS SHOWN BY THE HBC INDICATION- A HEALTHY FETAL HEART RATE IS TYPICALLY HIGHER THAN THE MATERNAL HEART RATE. FETAL HEART RATE ACCELERATED DURING CONTRACTIONS- A HEALTHY FETUS WOULD HAVE HEART RATE DECELERATIONS DURING MATERNAL CONTRACTIONS. MULTIPLE MATERNAL PARAMETERS TO INDICATE THE MOTHER WAS AT HIGH RISK FOR A COMPLICATED BIRTHING PROCESS, I.E. SHE WAS OVERWEIGHT, TACHYCARDIC, AND FEVERISH. THE OB TEAM ATTEMPTED TO USE A FETAL SCALP ELECTRODE (FSE) TO OBTAIN A FETAL HEART RATE DIRECTLY ON FOUR OCCASIONS WITH TWO DIFFERENT ELECTRODES. THEY OBSERVED NO GOOD SIGNAL FROM THE FSE ATTEMPTS AND CONCLUDED THE ELECTRODES WERE DEFECTIVE, INSTEAD OF CONCLUDING THERE WAS A PROBLEM WITH THE FETUS. ONE OF THE OBSTETRICIANS COMMUNICATED THEY DO NOT LOOK AT THE MONITOR STRIP CHART AT ALL. ANOTHER MEMBER OF THE OB TEAM COMMUNICATED THEY DIDN'T KNOW ABOUT OVERLAPPING HEARTRATES AND, THEREFORE, DID NOT UNDERSTAND THE INDICATIONS. THE OBSTETRICIANS COMMUNICATED THEY DID NOT READ THE MONITOR USER'S MANUAL AND DID NOT UNDERSTAND HEARTBEAT COINCIDENCE. THE OBSTETRICIANS APPLIED, REMOVED, AND THEN APPLIED SPO2 AGAIN. WHEN SPO2 WAS APPLIED AND INDICATED A MATERNAL HEART RATE THAT WAS OVERLAPPING WITH THE FETAL HEART RATE, APPROPRIATE ACTIONS WERE NOT TAKEN. THE OBSTETRICIANS DID NOT CONSIDER THE TWO HEART BEATS WERE BOTH FROM THE MOTHER AND THAT THE FETAL HEART BEAT WAS NOT BEING DETECTED. GE HEALTHCARE PROVIDED TRAINING ON THE DEVICE WHICH WAS ATTENDED BY HOSPITAL STAFF SEVERAL MONTHS PRIOR TO THE INCIDENT. THE HOSPITAL IS RESPONSIBLE FOR ENSURING THEIR CLINICIANS ARE PROPERLY TRAINED ON THE DEVICE THROUGH PERSONNEL TURNOVER CYCLES, ETC. THE GE TRAINING WAS PROVIDED ONE TIME ONLY AND WAS NOT PURCHASED AGAIN FOR NEW CLINICIANS THAT DID NOT RECEIVE THE ORIGINAL TRAINING. IT WAS CONCLUDED THAT THE ROOT CAUSE WAS USER ERROR INTERPRETING THE CLINICAL SITUATION OF THE MOTHER AND THE FETUS.

    Description of Event or Problem · 1

    GE HEALTHCARE HAS RECEIVED NOTIFICATION OF A DEATH OF A FETUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469705 COROMETRICS MONITOR PERINATAL MONITORING SYSTEM HGM WIPRO GE HEALTHCARE PRIVATE LTD 259 CX-C

    Patients

    Seq Age Sex Outcome Treatment
    1 Death