BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICAID

    MDR report key: 4113938 · Received August 13, 2014

    Report

    Report Number
    1000589001-2014-00003
    Event Type
    Injury
    Date Received
    August 13, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS
    Product Code
    HGM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO ARJOHUNTLEIGH BY THE NURSE: ON (B)(6) 2014, THERE WAS AN AUDIBLE FETAL SCALP ELECTRODE (FSE) MONITOR SHOWING A FETAL HEART RATE (FHR) OF 150 BEATS PER MINUTE (BPM). THE MONITOR'S SCREEN WAS SHOWING THE FHR AS 50 BPM. THE NURSE REPORTED THAT SUBSEQUENTLY A CESAREAN SECTION (C-SECTION) MAY HAVE BEEN PERFORMED BASED ON THE DATA OBSERVED FROM THE MONITOR'S SCREEN RATHER THAN THE AUDIBLE FHR. TO DATE THERE ARE NO AVAILABLE DETAILS AS TO THE OUTCOME OF THE EVENT REGARDING THE MOTHER OF INFANT'S CONDITION. ON (B)(6) 2014, THE NURSE REVIEWED DOCUMENTATION OF THE EVENT AND SPOKE WITH THE STAFF AT THE FACILITY. THE NURSE REPORTED THAT FROM INFORMATION OBTAINED DURING THE DISCUSSION, IT APPEARED THAT THERE WAS CONFUSION SURROUNDING THE RECORDING OF THE FHR AS WELL AS THE MODE OF TRANSMISSION (FSE VERSUS AN ABDOMINAL TRANSDUCER). THE DOCUMENTATION REVIEWED INDICATED THE FHR WAS AUDIBLE AT A RATE OF 120-130 BPM, HOWEVER, THE FHR RECORDED FROM THE FSE WAS 50 BPM WHICH WOULD BE CONSIDERED BRADYCARDIC. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE FILED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483189 SONICAID HGM HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS FM830ENCORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R