BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALTH BUDDY 2 APPLIANCE

    MDR report key: 1047824 · Received May 16, 2008

    Report

    Report Number
    3004142783-2008-00001
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    April 18, 2008
    Report Date
    May 14, 2008
    Manufacturer
    HEALTH HERO NETWORK, INC.
    Product Code
    DRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH BUDDY APPLIANCE IS INDICATED FOR USE IN NON-CLINICAL SETTINGS TO COLLECT AND TRANSMIT HISTORICAL DATA TO HEALTHCARE PROFESSIONALS TO HELP SUPPORT EFFECTIVE MANAGEMENT OF THEIR PTS. THE HEALTH BUDDY APPLIANCE IS NOT INTENDED TO PROVIDE AUTOMATED TREATMENT DECISIONS, NOR INTENDED FOR USE AS A SUBSTITUTE FOR A HEALTHCARE PROFESSIONAL'S JUDGMENT. ALL PT MEDICAL DIAGNOSIS AND TREATMENT ARE TO BE PERFORMED UNDER THE SUPERVISION AND OVERSIGHT OF A HEALTHCARE PROFESSIONAL. THE INTENDED USE IS NOT TO PROVIDE AUTOMATED TREATMENT DECISIONS, YET THE PT WAS NOT SEEN BY HEALTH CARE PROFESSIONAL BEFORE THE MEDICATIONS WERE ADJUSTED.

    Description of Event or Problem · 1

    BASED ON INCORRECT DATES FROM BLOOD PRESSURE CUFF CONNECTED TO HEALTH BUDDY 2 APPLIANCE, HIGH BLOOD PRESSURES TAKEN IN THE PAST WERE INCORRECTLY INTERPRETED AS BEING IN THE PRESENT. THE PHYSICIAN ADJUSTED THE PT'S MEDICATION ON THE BASIS OF THE RESULTS REPORTED, WITHOUT SEEING PT, RESULTING IN SYMPTOMS OF DIZZINESS AND LIGHTHEADEDNESS. THE PT WAS ADMITTED TO THE HOSPITAL THE WEEKEND OF (B) (6), AS A RESULT OF AN UNRELATED INCIDENT RELATED TO PRE-EXISTING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALTH BUDDY 2 APPLIANCE PHYSIO. SIGNAL TRANSMITTER AND RECEIVER DRG HEALTH HERO NETWORK, INC. HEALTH BUDDY 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1