BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NICVIEW 2.0 CAMERA

    MDR report key: 23631176 · Received November 24, 2025

    Report

    Report Number
    9612197-2025-00012
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 17, 2025
    Manufacturer
    NATUS MEDICAL INCORPRATED
    Product Code
    FWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER WAS CONTACTED FOR FURTHER INFORMATION RELATING TO THIS ISSUE WHICH WAS REPORTED TO A THIRD-PARTY TECHNICIAN WHO WAS ON SITE FOR AN INSTALL TECHNICAL SERVICE SENT THE CUSTOMER AN EMAIL AND ALSO TRIED TO PHONE THE CUSTOMER 21 NOV & AGAIN 9 DEC. CASE WAS CLOSED AS THERE WAS NO RESPONSE. NO PATIENT OR USER WAS HARMED. RISK REVIEW: (B)(4) REV B - RISK ANALYSIS FOR NICVIEW 2.0 HAZARD 2.2. CAUSE - SHORT CIRSUIT DUE TO DAMAGED LOW VOLTAGE CABLE COMPONENTS, SUCH AS MICRO-USB CONNECTOR, CABLE, ETC. EFFECT - FIRE - FIRE - SMOKE INHALATION, SECOND DEGREE BURNS, THIRD DEGREE BURNS AND/OR ENVIRONMENTAL DAMAGE. RESIDUAL RISK - MODERATE. THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN QMS-000018 RISK MANAGEMENT SYSTEM PROCEDURE (SENSORY), HAZARDS THAT HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH KNOWN STANDARDS CAN BE PRESUMED TO BE CONSISTENT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE.

    Description of Event or Problem · 0

    DURING A SITE VISIT DONE BY A NURSE REPORTED TO THE TECHNICIAN THAT A NICVIEW CAMERA HAD SPARKED AND ARCED. NO PATIENT OR USER HARMED BY THIS EVENT.

    Description of Event or Problem · 0

    DURING A SITE VISIT DONE BY MERA, A NURSE REPORTED TO THE TECHNICIAN THAT A NICVIEW CAMERA HAD SPARKED AND ARCED. NO PATENT OR USER HARM CAUSED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2629713 NICVIEW 2.0 CAMERA NICVIEW 2.0 CAMERA FWC NATUS MEDICAL INCORPRATED NVARM2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown