BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 10468892 · Received August 28, 2020

    Report

    Report Number
    3011196194-2020-00032
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Date of Event
    July 30, 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

    THIS DEVICE IS NOT INTENDED TO UNDERGO CHARGING. DEVICE IS INTENDED TO EITHER BE USED WITH BATTERY POWER OR WITH ELECTRICAL POWER. USER ALSO DID NOT USE THE APPROPRIATE CHARGER WHILE PLUGGING IN THEIR DEVICE, WHICH MANUFACTURER FEELS LED TO BATTERIES LEAKING/MELTING. 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 AFTER CHARGING THEIR HTN MONITOR, THE DEVICE WAS EXTREMELY WARM. UPON OPENING THE BATTERY COMPARTMENT, THE PATIENT FOUND THAT THE BATTERIES HAD MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932748 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN LIVONGO HEALTH INC UA-651BLE-LIV

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR