BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALS STREAM

    MDR report key: 11769764 · Received May 4, 2021

    Report

    Report Number
    3006648320-2021-00001
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    February 13, 2021
    Report Date
    April 14, 2021
    Manufacturer
    CAPSULE TECHNOLOGIE, SAS
    Product Code
    MWI
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A CAPSULE NEURON RUNNING THE CAPSULE VITALS STREAM APPLICATION CAUGHT FIRE IN A PATIENT ROOM. NO INJURY WAS INVOLVED. VITALS STREAM IS SOFTWARE MEDICAL DEVICE DATA SYSTEM, A 510(K) EXEMPT CLASS I MEDICAL DEVICE. THE FIRE ORIGINATED IN THE INTERNAL BATTERY PACK WHICH INCLUDES THREE LITHIUM ION CELLS ROOT CAUSE INVESTIGATION IS CURRENTLY BEING PERFORMED BY THE NEURON MANUFACTURER, THE BATTERY PACK MANUFACTURER AND THE LITHIUM ION CELL MANUFACTURER. THE INITIAL OBSERVATIONS ARE THAT THE NEURON MAY HAVE BEEN MOUNTED IN SUCH A WAY AS TO PUT PHYSICAL PRESSURE ON THE BATTERY PACK, WHICH COULD HAVE CAUSED A MALFUNCTION LEADING TO THE LITHIUM ION CELLS IGNITING. THIS IS TO BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670716 VITALS STREAM MEDICAL DEVICE DATA SYSTEM MWI CAPSULE TECHNOLOGIE, SAS SL-NU3-UMPC-IOM7S

    Patients

    Seq Age Sex Outcome Treatment
    1