BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICAID

    MDR report key: 2340269 · Received November 14, 2011

    Report

    Report Number
    1000589001-2011-00001
    Event Type
    Malfunction
    Date Received
    November 14, 2011
    Date of Event
    September 28, 2011
    Report Date
    October 18, 2011
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD.
    Product Code
    HGM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH ((B)(4)) ON BEHALF OF THE MANUFACTURER HUNTLEIGH HEALTHCARE ((B)(4)). ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    THE SONICAID FETAL MONITOR POWER SUPPLY HAD AN ELECTRONIC FAILURE WHICH CAUSED BURNING ON THE DC SIDE OF THE POWER SUPPLY. THIS LEAD TO FAILURE OF THE MONITOR. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICAID BD FETAL MONITOR HGM HUNTLEIGH HEALTHCARE LTD. BD4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other