BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAN S31 FETAL HEART MONITOR

    MDR report key: 1886196 · Received August 25, 2010

    Report

    Report Number
    3004729605-2010-00003
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    March 2, 2006
    Report Date
    August 23, 2010
    Manufacturer
    NEOVENTA MEDICAL AB
    Product Code
    HEO
    PMA / PMN Number
    P020001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO FROM THE VOLUNTARY REPORT: CASE REPORT: (B)(6). THE CASE DOES NOT REPRESENT A TYPICAL COMPLAINT. NO CUSTOMER OR RESPONSIBLE CLINICIAN HAS APPROACHED NEOVENTA COMPLAINING OF AN UNEXPECTED BEHAVIOUR OF STAN. THE CASE HAS BECOME KNOWN TO NEOVENTA EMPLOYEES (B)(4). NEOVENTA'S MEDICAL ADVISOR, (B)(4) (NOT EMPLOYED IN NEOVENTA) GOT AWARE OF THE CASE IN (B)(4) 2007 (MORE THAN ONE YEAR AFTER THE INCIDENT) WHEN THE HOSPITAL APPROACHED HIM WITH A REQUEST TO ANALYZE THE RECORDINGS OF THE CASE. TRAINING HAS BEEN PERFORMED FIRST BY THREE USERS FROM THE CLINIC VISITING THE NEOVENTA OFFICE 2003. AFTERWARDS CONTINUOUS INTERNAL TRAINING AT CLINIC HAS BEEN PERFORMED. OUR CONCLUSION IS THAT: THERE WAS NO DEFICIENCY ON THE STAN MONITOR; THE STAN SIMPLIFIED CLINICAL GUIDELINES WERE NOT FOLLOWED, AS THEY RECOMMEND IMMEDIATE DELIVERY IN THE PRESENCE OF A PRETERMINAL TRACE. THE PROBLEM MAY BE POSED IN CLINICAL PRACTICE, WITH THE ASSESSMENT AND CLASSIFICATION OF THE FHR TRACE. THIS REPORT IS CLASSIFIED AS FINAL. INVESTIGATION HAS BEEN COMPLETED AND ROOT CAUSE HAS BEEN DETERMINED, TO THE EXTENT POSSIBLE.

    Description of Event or Problem · 1

    THE STAN CLINICAL GUIDELINES WERE NOT FOLLOWED IN THE PRESENCE OF AN ABNORMAL CTG. THE TRACING WAS PRETERMINAL AND IMMEDIATE DELIVERY WAS RECOMMENDED PER THE GUIDELINES. THE BABY WAS DELIVERED IN SERIOUS CONDITION. ADDITIONAL INFO: EVENT IN (B)(6). DATE OF INCIDENT: 2006-(B)(6). NEOVENTA GOT AWARE: 2007-(B)(6). SERIOUS INJURY FOR PT (BABY). USER ERROR; THE STAN CLINICAL GUIDELINES WERE NOT FOLLOWED, AS THEY RECOMMEND IMMEDIATE DELIVERY IN THE PRESENCE OF A "PRETERMINAL" TRACE. ADD'L INFO FROM VOL REPORT: PT MONITORING SYSTEM, CARDIOGRAPHIC.

    Devices

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

    Patients

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