BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAN S 31 FETAL HEART MONITOR

    MDR report key: 1819778 · Received August 25, 2010

    Report

    Report Number
    3004729605-2010-00009
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    October 26, 2009
    Report Date
    August 25, 2010
    Manufacturer
    NEOVENTA MEDICAL AB
    Product Code
    HEO
    PMA / PMN Number
    P020001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DIGITAL FEKG DATA HAVE BEEN ANALYZED AND CONTAIN EXTREMELY HIGH P-WAVES. IT'S NOT CLEAR IF THIS IS PART OF THE ROOT CAUSE OF THE INCIDENT. BUT FEKG APPEARANCE AND PARTLY SOME SIGNAL INTERFERENCE HAVE CONTRIBUTED TO THE LOW QUALITY OF CTG AND ST-CURVE ANALYSIS. THE OPERATOR TURNED OFF THE ST ANALYSIS FUNCTION DESPITE THAT THIS IS NOT A RECOMMENDED ACTION. THE ANALYSIS OF DATA SHOWS THAT ST EVENTS WOULD HAVE APPEARED APPROX. 1 HOUR BEFORE DELIVERY, UNLESS THE FUNCTION HAD BEEN TURNED OFF. HOWEVER, IT'S UNCLEAR WHETHER THIS HAD AFFECTED THE OUTCOME. NEOVENTA REQUESTED THE PIB FOR FURTHER TECHNICAL ANALYSIS. ON (B)(6)2009 PIB ARRIVED AT NEOVENTA. INVESTIGATION BY TECHNICAL SUPPORT SHOWS THAT IT WORKS ACCORDING TO SPECIFICATIONS. THIS WAS COMMUNICATED TO THE BIO. MED AT (B)(6) HOSPITAL ON (B)(6)2010. DETAILED INVESTIGATION HAS BEEN MADE IN TERMS OF BOTH SIGNAL QUALITY AND CURRENT HARDWARE AND INCLUDES MORE DETAILED INFO. CORRECTIVE ACTION: IT IS STRESSED THAT THE CLEANING INSTRUCTIONS FOR LEG PLATE AND SKIN ELECTRODE CONNECTION MUST BE FOLLOWED. THE DEVICE FUNCTIONED ACCORDING TO SPECIFICATIONS. THERE WERE UNUSUALLY LARGE FEKG COMPLEXES. THIS CONTRIBUTED TO POORER COVERAGE OF THE FHR, BUT ENOUGH TO INTERPRET THE FHR CURVE. THE OPERATOR DISABLED THE ST ANALYSIS APPROX 1.5 HOURS BEFORE DELIVERY. THE REASON IS UNK. WHEN ST IS DISABLED, THE OPERATOR IS WARNED THAT ST FUNCTION WILL NO LONGER FUNCTION. THE CUSTOMER CONFIRMS THERE'S BEEN NO PROBLEMS WITH SIGNAL QUALITY SINCE IMPLEMENTATION OF THE RECOMMENDED CLEANING INSTRUCTIONS. THE INITIAL REPORTABILITY DECISION INDICATED THIS WAS NOT A REPORTABLE EVENT IN THE U.S., (B)(4).

    Description of Event or Problem · 1

    THE FETAL HEART RATE AND ST REGISTRATION WAS POOR DURING LABOR. THE STAFF DISABLED THE ST FUNCTION DURING PARTS OF LABOR, WHICH IS NOT A RECOMMENDED ACTION. THE BABY WAS BORN WITH LOW APGAR, WAS RESUSCITATED AND TRANSFERRED TO NICU. AT FOLLOW-UP IN (B)(6) 2010, BRAIN MR SHOWS ISCHEMIA AND THE BABY SHOWS SIGNS OF PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAN S 31 FETAL HEART MONITOR HEO: OBSTETRIC DATA ANALYZER HEO NEOVENTA MEDICAL AB STAN S31 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Hospitalization| L| R| S