BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHCHILD OBSTETRICAL PATIENT DATA MONITORING SYS

    MDR report key: 283661 · Received June 23, 2000

    Report

    Report Number
    1045510-2000-00008
    Event Type
    Death
    Date Received
    June 23, 2000
    Date of Event
    November 7, 1999
    Report Date
    June 23, 2000
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HGM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT INVOLVED IN A CAR ACCIDENT AND ARRIVED AT HOSP EXPERIENCING CONTRACTIONS. MOTHER WAS BRIEFLY MONITORED WITH WATCHCHILD DEVICE. WHEN NO FETAL HEARTBEAT WAS DETECTED, THE DEVICE WAS DISCONTINUED. CHILD DELIVERED STILLBORN, MOTHER DIED SEVEN HOURS LATER. THERE IS NO MEDICAL DEVICE IMPLICATION ASSOCIATED WITH THIS EVENT. HOSP REQUESTED AUDIT TRAIL OF EVENTS FOR CONFIDENTIALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WATCHCHILD OBSTETRICAL PATIENT DATA MONITORING SYS PATIENT MONITORING SYSTEM HGM HILL-ROM, INC. 2519 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death