BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILLIPS

    MDR report key: 1843894 · Received September 20, 2010

    Report

    Report Number
    1843894
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    December 11, 2009
    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

    MONITORING RECORDER SWITCHING BETWEEN MOM AND BABY. MOTHERS HR 100-110, FETAL HR 120S. NURSE CONFIRMED AUDIBLY THAT FETAL HR WAS 120S. MONITOR TRACING 110. FETAL SCALP ELECTRODE PLACED.

    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 25 YR Hospitalization