BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALTHDYNE

    MDR report key: 144204 · Received January 15, 1998

    Report

    Report Number
    MW1012808
    Event Type
    Injury
    Date Received
    January 15, 1998
    Date of Event
    November 6, 1997
    Report Date
    January 12, 1998
    Manufacturer
    HEALTHDYNE, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFANT WAS DISMISSED FROM THE HOSP WITH APNEA MONITOR. THE MONITOR MALFUNCTIONED WHICH RESULTED IN MULTIPLE BRADYCARDIC READINGS. THE INFANT WAS TAKEN TO THE ER AND WAS FOUND TO HAVE NO EVIDENCE OF BRADYCARDIA. THE MONITOR HAD BEEN PLACED UNDER THE TELEVISION REMOTE CONTROL LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALTHDYNE APNEA MONITOR DRT HEALTHDYNE, INC. 970SE *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DAY Hospitalization