BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALTH BUDDY 3 APPLIANCE

    MDR report key: 2357792 · Received October 12, 2011

    Report

    Report Number
    3004142783-2011-00001
    Event Type
    Malfunction
    Date Received
    October 12, 2011
    Date of Event
    September 21, 2011
    Report Date
    October 10, 2011
    Manufacturer
    HEALTH HERO NETWORK, INC., A ROBERT BOSCH COMPANY
    Product Code
    DRG
    PMA / PMN Number
    K080091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S BLOOD SUGAR APPARENTLY BOTTOMED OUT WHILE MAKING BREAKFAST. THE PATIENT'S GIRLFRIEND CAME DOWN AND DISCOVERED THE PATIENT UNRESPONSIVE AND HAVING A SEIZURE ON THE KITCHEN FLOOR. THE PATIENT'S GIRLFRIEND TRIED TO DIAL 911 FOUR TIMES BUT EACH TIME THE (B)(4) WAS TRYING TO MAKE A CONNECTION OUT AND WOULD NOT RELEASE THE LINE. ON THE FIFTH TRY, THE PATIENT'S GIRLFRIEND WAS ABLE TO GET A DIAL TONE AND DIAL 911. WHEN PARAMEDICS ARRIVED THEY DETERMINED THE ISSUE WAS WITH THE PATIENT'S BLOOD SUGAR LEVELS AD WERE ABLE TO TAKE CARE OF THE PATIENT WITHOUT HAVING TO TAKE HIM TO THE HOSPITAL. CURRENTLY, THE PATIENT IS DOING OKAY WITH NO APPARENT ISSUES FROM THIS EPISODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALTH BUDDY 3 APPLIANCE HB3 APPLIANCE DRG HEALTH HERO NETWORK, INC., A ROBERT BOSCH COMPANY 096-716-001

    Patients

    Seq Age Sex Outcome Treatment
    1