BEUDAMED
    FDA Adverse Event Death Summary report: N

    8040A

    MDR report key: 48497 · Received November 11, 1996

    Report

    Report Number
    2951286-1996-90001
    Event Type
    Death
    Date Received
    November 11, 1996
    Date of Event
    September 21, 1996
    Report Date
    November 4, 1996
    Manufacturer
    HEWLETT-PACKARD GMBH
    Product Code
    KXN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MOTHER WAS ADMITTED WITH CONTRACTIONS AND PUT ON THE FETAL MONITOR. A HEART RATE OF APPROX 145 WAS BEING RECEIVED VIA THE US TRANSDUCER. THE PT AT SOME POINT WENT TO THE BATHROOM AND WHEN SHE RETURNED AND WAS PUT BACK ON THE MONITOR, NO HEART RATE COULD BE FOUND. UNKNOWN MEASURES WERE THEN TAKEN BY THE NURSING STAFF. THE BABY WAS DELIVERED STILLBORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8040A CARDIOTOCOGRAPH KXN HEWLETT-PACKARD GMBH 8040A *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 * Death