BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAN FETAL HEART MONITOR

    MDR report key: 1819698 · Received August 25, 2010

    Report

    Report Number
    3004729605-2010-00007
    Event Type
    Death
    Date Received
    August 25, 2010
    Date of Event
    March 18, 2008
    Report Date
    August 19, 2010
    Manufacturer
    NEOVENTA MEDICAL AB
    Product Code
    HEO
    PMA / PMN Number
    P020001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A NUMBER OF DIFFERENT CIRCUMSTANCES APPEAR TO BE THE ROOT CAUSE. THE DEVICE APPEARS TO HAVE INDICATED A PATHOLOGICAL CTG (FHR) PATTERN, WHICH WAS NOT MANAGED ACCORDING TO THE GUIDELINES. THERE ARE NO SPECIFIC ALARMS FOR THE PATHOLOGICAL CTG ONLY THE TRACING PATTERN. THE FOLLOWING ISSUES REGARDING LACK OF QUALITY AND PATIENT SAFETY WERE IDENTIFIED BY (B)(6): ORGANIZATION, WORKLOAD AND AUTHORITIES. INDIVIDUAL RESPONSIBILITY FOR PT. ABSENCE OF WARNINGS FOR PATHOLOGICAL CTG IN THE STAN DEVICE. LIMITED KNOWLEDGE OF INTRAUTERINE PRESSURE TRANSDUCERS. THE DEVICE REMAINS AT THE HOSPITAL. THE HOSPITAL HAS NOT CONTACTED NEOVENTA REGARDING THIS CASE. THE DEVICE IS NOT CONSIDERED THE ROOT CAUSE, AND NEOVENTA HAS NOT HAD ACCESS TO IT. IT IS UNCLEAR IF THE STAN S21 OR S31 WAS USED. ALTHOUGH, THE INITIAL REPORTABILITY DECISION INDICATED THAT THIS WAS NOT A REPORTABLE EVENT IN THE UNITED STATES, IN RESPONSE TO THE FDA WARNING LETTER OF 08/04/2010, AND CAPA PROJECT (B)(4), THIS EVENT WILL BE REPORTED IN THE US ACCORDING TO THE TABLE BELOW. WE ARE AWARE THAT REPORTING TIMELINES CANNOT BE MET WITH THE RETROSPECTIVE REPORTING.

    Description of Event or Problem · 1

    NEOVENTA MEDICAL AB RECEIVED AN INFO COPY OF A DECISION REPORT FROM (B)(6) BOARD OF HEALTH AND WELFARE ON 12/17/2008. THE REPORT, DATED 12/11/2008, DNR (B)(4)2008 REPORTED THE DEATH OF A NEWBORN FETUS DUE TO A NUMBER OF VERY DIFFICULT CIRCUMSTANCES DURING THE LABOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death THE (B)(6) REPORT HAD NO COMMENTS ABOUT| ANY FAULT OF THE STAN MONITOR. STAFF DID NOT| FOLLOW PROCEDURES/GUIDELINES.| THE EVENT WAS NOT PROPERLY REPORTED TO NEOVENTA.