BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FETAL HEART MONITOR

    MDR report key: 359455 · Received November 6, 2001

    Report

    Report Number
    MW1023285
    Event Type
    Injury
    Date Received
    November 6, 2001
    Date of Event
    September 29, 2001
    Report Date
    October 29, 2001
    Manufacturer
    PHILLIPS MEDICAL SYSTEMS
    Product Code
    KXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FETAL HEART MONITOR STOPPED RECORDING FETAL HEART RATE. EXTERNAL ULTRASOUND MONITOR CHANGED TWICE - CONTINUES TO NOT RECORD. SENT TO BIO FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49583 FETAL HEART MONITOR FETAL HEART MONITOR KXN PHILLIPS MEDICAL SYSTEMS M1350A *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention