BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATUS NICVIEW 2

    MDR report key: 14436064 · Received May 19, 2022

    Report

    Report Number
    14436064
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    May 4, 2022
    Report Date
    May 10, 2022
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CLINICAL ENGINEERING HAS IDENTIFIED THE FOLLOWING CONCERN: THE FLEX ARMS ON 15 CAMERAS HAVE LOST RIGIDITY WHICH PREVENTS THE CAMERA FROM FUNCTIONING AS INTENDED (CAMERA IS HELD UP TO VIEW THE BABY). NO PATIENTS WERE HARMED OR INVOLVED. MANUFACTURER RESPONSE FOR CAMERA FLEX ARM ACCESSORY, NATUS NICVIEW 2 (PER SITE REPORTER). A COMPANY REPRESENTATIVE WAS NOTIFIED BY HOSPITAL CLINICAL ENGINEERING DEPT. THE REPRESENTATIVE STATED THAT THERE IS NOTHING PLANNED AT THIS TIME TO PREVENT OR CORRECT THIS ISSUE DUE TO NO OTHER HOSPITALS THAT ARE EXPERIENCING THIS PROBLEM. REPLACEMENTS HAVE BEEN ORDERED BY THE HOSPITAL BUT ARE ON BACKORDER AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2095663 NATUS NICVIEW 2 CAMERA, TELEVISION, SURGICAL, WITH AUDIO FWC NATUS MEDICAL INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown