BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVWATCH PATIENT MONITOR

    MDR report key: 14695107 · Received June 15, 2022

    Report

    Report Number
    14695107
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    February 13, 2022
    Report Date
    February 22, 2022
    Manufacturer
    IVWATCH, LLC
    Product Code
    PMS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BEDSIDE RN NOTICED SPARKS COMING FROM EXPOSED WIRES COMING OUT OF THE IV WATCH DEVICE IN HER PATIENT'S ROOM. SHE IMMEDIATELY UNPLUGGED DEVICE, POWERED IT OFF AND RED-TAGGED THE DEVICE. HTM- BIOMEDICAL DEPT WAS CALLED TO PICK UP THIS DEVICE FROM THE OFFICE SO THAT IT WOULD NOT ACCIDENTALLY GO BACK INTO GENERAL USE. DEVICE WAS LATER COLLECTED BY A MEMBER OF HTM. MANUFACTURER RESPONSE FOR IV WATCH AND IV WATCH BAT, IVWATCH 400 (PER SITE REPORTER). THEY ARE SENDING A NEW POWER BRICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2836033 IVWATCH PATIENT MONITOR PERIPHERAL INTRAVENOUS (PIV) INFILTRATION MONITOR PMS IVWATCH, LLC MODEL 400 POWER BRICK C1547A, POWER BRI

    Patients

    Seq Age Sex Outcome Treatment
    1 2920 DA Male