BEUDAMED
    FDA Adverse Event Other Summary report: N

    STAN S31 FETAL HEART MONITOR

    MDR report key: 1819977 · Received August 25, 2010

    Report

    Report Number
    3004729605-2010-00008
    Event Type
    Other
    Date Received
    August 25, 2010
    Date of Event
    March 9, 2009
    Report Date
    August 19, 2010
    Manufacturer
    NEOVENTA MEDICAL AB
    Product Code
    HEO
    PMA / PMN Number
    P020001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE INITIAL REPORTABILITY DECISION INDICATED THAT THIS WAS NOT A REPORTABLE EVENT IN THE US, IN RESPONSE TO THE FDA WARNING LETTER OF AUGUST 4, 2010, AND CAPA PROJECT (B)(4), THIS EVENT WILL BE REPORTED IN THE US. WE ARE AWARE THAT REPORTING TIMELINES CANNOT BE MET WITH THE RETROSPECTIVE REPORTING.

    Description of Event or Problem · 1

    THE STAN UNIT STARTED TO SMELL LIKE BURNING PLASTIC. A NURSE TRYING TO TURN THE UNIT OFF TOUCHED THE MAIN SWITCH, AND IT WAS SO HOT SHE INSTANTLY PULLED HER FINGER AWAY. THERE WAS NO REMAINING OR RESIDUAL MARK, ETC. NOTED BY THE MIDWIFE ON HER FINGER.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE NOTED