BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALCONNECT

    MDR report key: 10116393 · Received June 3, 2020

    Report

    Report Number
    3010830833-2020-00001
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    May 20, 2020
    Report Date
    May 28, 2020
    Manufacturer
    VITALCONNECT, INC.
    Product Code
    DRG
    UDI-DI
    00850490007139
    PMA / PMN Number
    K193343
    Removal / Correction Number
    C3010830833-05292020-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO INITIAL REPORTER: "THIS IS A PILOT AND IS BEING USED IN PARALLEL TO MANUAL COLLECTION OF VITAL SIGNS AS A VALIDATION PHASE OF THE PROJECT, THEREFORE THERE WAS NO IMPACT TO PATIENT CARE, INCREASED MONITORING REQUIRED, OR ADVERSE OUTCOMES." A SOFTWARE DEFECT WAS IDENTIFIED AS THE ROOT CAUSE OF THIS EVENT, WHICH MEETS THE DEFINITION OF A MALFUNCTION; THEREFORE, A CORRECTION HAS BEEN INITIATED. NOTIFICATION TO AFFECTED USERS WAS INITIATED ON 05/21/2020. WE ANTICIPATE COMPLETION OF CORRECTION BY END OF MAY 2020. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER NOTICED A PATIENT HAD A LOWERED SPO2 READING THAT SHOULD HAVE TRIGGERED A VISTACENTER NOTIFICATION TO THE CARE TEAM, BUT NO NOTIFICATION WAS FOUND. THE PATIENT'S OXYGEN SATURATION RECOVERED, BUT WAS SIGNIFICANTLY LOW, EXPOSING THE PATIENT TO POTENTIAL HYPOXIA FOR A SHORT WINDOW OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577823 VITALCONNECT VISTACENTER DRG VITALCONNECT, INC. VISTACENTER N/A 00850490007139

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR