BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODY GUARDIAN

    MDR report key: 5917306 · Received August 28, 2016

    Report

    Report Number
    MW5064449
    Event Type
    Injury
    Date Received
    August 28, 2016
    Date of Event
    August 28, 2016
    Report Date
    August 28, 2016
    Manufacturer
    PREVENTICE SOLUTIONS
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COMPANY REPORTS THAT MY HEART RATE NEVER GOT BELOW 50 BEATS PER MINUTE ON ALL THE LISTED MEDICAL EQUIPMENT. MY HEART NEVER REACHED 50 BEATS WHILE HAVING THE MONITORS AND TELEMETRY BOTH ON. PRIOR TO YESTERDAY, I HAD BEEN KEEPING TRACKED USING A COMBINATION OF AT HOME DEVICES AS A QUALITY CHECK BECAUSE THE PREVIOUS TEST REPORTS WERE SO FAR OFF FROM THE ACTUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561295 BODY GUARDIAN BODY GUARDIAN DSI PREVENTICE SOLUTIONS BG0054340

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| O