BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALTHDYNE

    MDR report key: 127650 · Received October 22, 1997

    Report

    Report Number
    MW1012327
    Event Type
    Injury
    Date Received
    October 22, 1997
    Date of Event
    September 8, 1997
    Report Date
    October 10, 1997
    Manufacturer
    HEALTHDYNE, INC.
    Product Code
    FLS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A SET OF TWINS SENT HOME ON APNEA MONITORS. THE APNEA MONITOR FOR ONE TWIN HAD MULTIPLE BRADYCARDIA ALARMS. THE BABY WAS ADMITTED TO THE HOSP BUT THERE WAS NO EVIDENCE OF BRADYCARDIA SPELLS. THE BABY WAS DISMISSED FROM THE HOSP THE FOLLOWING DAY. THE APNEA MONITOR WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 DAY Hospitalization