BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICAID

    MDR report key: 3110558 · Received April 11, 2013

    Report

    Report Number
    1419652-2013-00093
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 20, 2013
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS
    Product Code
    HEL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLIENT WAS USING AN (B)(4) TO MONITOR A WOMAN. WHEN THE ANALYSIS WAS PRINTED THE STV VALUE WAS ZERO AND THE CLINICIAN MADE THE DECISION TO PERFORM A CESAREAN SECTION. THE BABY WAS BORN WITH NO APPARENT PROBLEMS. MFR REF NUMBER 1000589001-2013-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156285 SONICAID FM800 RANGE OF FETAL MONITORS HEL HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS FM830ENCORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention