BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 10468877 · Received August 28, 2020

    Report

    Report Number
    3011196194-2020-00033
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Date of Event
    July 16, 2020
    Report Date
    August 28, 2020
    Manufacturer
    LIVONGO HEALTH INC
    Product Code
    DXN
    PMA / PMN Number
    K170196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HTN MONITOR HAVE NOT BEEN RETURNED TO THE MANUFACTURER. SHOULD THE DEVICE BE RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE RESULTS OF THE TESTING.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HIS BLOOD PRESSURE MONITOR HAD A BURNT SMELL WHERE THE BATTERIES WERE LOCATED AND ON THE INSIDE OF THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932590 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN LIVONGO HEALTH INC UA-651BLE-LIV

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR