BEUDAMED
    FDA Adverse Event Death Summary report: N

    SONICAID

    MDR report key: 3030183 · Received March 28, 2013

    Report

    Report Number
    1000589001-2013-00002
    Event Type
    Death
    Date Received
    March 28, 2013
    Report Date
    February 27, 2013
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS
    Product Code
    HGM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IS SUBMITTING THE REPORT ON BEHALF HUNTLEIGH (B)(4). ((B)(4)) FOR MORE DETAILS.

    Description of Event or Problem · 1

    CLINICIANS HAVE HAD DIFFICULTY DISTINGUISHING BETWEEN THE FHR AND MHR. THE CUSTOMER DID AN OPERATION AND A FETUS WAS STILL BORN YET THE FHR WAS SHOWING OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127474 SONICAID FM800 RANGE OF FETAL MONITORS HGM HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS FM830ENCORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death