BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILLIPS

    MDR report key: 1843889 · Received September 20, 2010

    Report

    Report Number
    1843889
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    February 18, 2010
    Report Date
    March 1, 2010
    Manufacturer
    PHILLIPS HEALTHCARE
    Product Code
    HGM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FETAL HEART RATE TRACING RECORDING 130-140. MATERNAL HEART RATE 138. FETAL HEART RATE CHECKED AUDIBLY AND DID NOT MATCH TRACING. TRACING RECORDING MATERNAL HEART RATE INSTEAD OF FETAL HEART RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILLIPS FETAL HEART RATE MONITOR HGM PHILLIPS HEALTHCARE M2703A/FM30

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization