BEUDAMED
    FDA Adverse Event Summary report: N

    SONICAID

    MDR report key: 2824588 · Received October 26, 2012

    Report

    Report Number
    1000589001-2012-00003
    Date Received
    October 26, 2012
    Report Date
    October 10, 2012
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS
    Product Code
    HGM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MANUFACTURER HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS. (B)(4). SPOKEN TO OUR DISTRIBUTOR ((B)(4)) AND GAVE THEM SOME QUESTIONS TO BE ASKED TO ALLOW US TO INVESTIGATE FURTHER. THE TEAM PRODUCT INVOLVED IN THIS INCIDENT WAS MANUFACTURED BY OXFORD INSTRUMENTS IN (B)(4) IN 2001. OXFORD INSTRUMENTS WERE OWNED BY A PARENT COMPANY (B)(4). HUNTLEIGH HEALTHCARE (B)(4).

    Description of Event or Problem · 1

    AN EMAIL WAS RECEIVED FROM OUR DISTRIBUTOR REGARDING A SONICAID MONITOR WHERE A BABY HAD DIED AND THE END USER CUSTOMER WOULD HAVE A DECLARATION ABOUT WHAT CAN BE DONE OR NOT WITH THAT TEAM IN REGARDS TO A SIGNAL LOSS ALARM. MORE INFO HAS BEEN REQUESTED, BUT NO INFO IS FORTHCOMING REGARDING THE EVENT AT THIS STAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICAID TEAM FETAL MONITORS HGM HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS TEAMCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death