BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO BLOOD PRESSUE MONITOR

    MDR report key: 11649062 · Received April 12, 2021

    Report

    Report Number
    3011196194-2021-00007
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 2, 2021
    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 LIVONGO BLOOD PRESURE MONITOR HAS 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 CUSTOMER REPORTED THAT THEIR HYPERTENSION MONITOR STARTED TO SMELL LIKE IT WAS SMOKING WHEN THEY WERE USING IT. THE CUSTOMER STATED THAT THE BACK OF THE HYPERTENSION MONITOR HAD MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544790 LIVONGO BLOOD PRESSUE MONITOR BLOOD PRESSURE MONITOR DXN LIVONGO HEALTH INC HT900

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization