BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO BLOOD PRESSURE MONITOR

    MDR report key: 16627936 · Received March 28, 2023

    Report

    Report Number
    3011196194-2023-00026
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    February 18, 2023
    Report Date
    March 22, 2023
    Manufacturer
    LIVONGO HEALTH, INC.
    Product Code
    DXN
    PMA / PMN Number
    K131395
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT REPORTED THAT THE BLOOD PRESSURE CUFF WOULD NOT STOP INFLATING, CAUSING PAIN AND BRUISING.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THE BLOOD PRESSURE CUFF WOULD NOT STOP INFLATING, CAUSING PAIN AND BRUISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28467 LIVONGO BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR DXN LIVONGO HEALTH, INC. HT900

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown