BEUDAMED
    FDA Adverse Event Death Summary report: N

    SONICAID

    MDR report key: 2444284 · Received February 8, 2012

    Report

    Report Number
    1000589001-2012-00001
    Event Type
    Death
    Date Received
    February 8, 2012
    Date of Event
    December 28, 2011
    Report Date
    January 6, 2012
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS
    Product Code
    HGM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) ON BEHALF OF THE MANUFACTURER HUNTLEIGH HEALTHCARE LTD. (REGISTRATION#1000589001). THE UNIT IS BEING RETURNED FROM (B)(6) HOSPITAL TO THE SERVICE DEPARTMENT AT (B)(6) FOR INVESTIGATION. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    A COMMUNICATION WAS RECEIVED FROM THE ADVERSE INCIDENT CENTRE OF THE (B)(6), STATING THAT AN INCIDENT HAD BEEN REPORTED BY (B)(6) HOSPITAL WITH REGARD TO AN FM830 FETAL MONITOR. THE REPORTED FAULT WITH THE MONITOR WAS "CTG DISPLAYING TRACE WITH FETAL HEART RATE OF 150BPM, BUT BABY WAS DEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICAID FM800 RANGE OF FETAL MONITOR HGM HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS FM830

    Patients

    Seq Age Sex Outcome Treatment
    1 Death