BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NICVIEW 2.0 CAMERA

    MDR report key: 23767936 · Received December 10, 2025

    Report

    Report Number
    9612197-2025-00013
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    December 4, 2025
    Report Date
    February 10, 2026
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT #: (B)(4) - RISK ANALYSIS FOR NICVIEW 2.0 HAZARD 2.2 CAUSE- SHORT CIRCUIT DUE TO DMAGED 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 CONSISTANT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. CUSTOMER REPLACED NVARM 2 WITHA SPARE AND THEY WERE REQUESTED TO RETURN THE DEFECTIVE DEVICE FOR INVESTIGATION: MULTIPLE ATTEMPTS TO GET THE DEFECTIVE PART BACK. 12 SEP REQUEST FOR DEFECTIVE DEVICE TO BE RETURNED. 12 OCT REQUEST FOR DEFECTIVE DEVICE TO BE RETURNED. 22 DEC REQUEST FOR DEFECTIVE DEVICE TO BE RETURNED. JAN 19 REQUEST FOR DEFECTIVE DEVICE TO BE RETURNED. JAN 25 REQUEST FOR DEFECTIVE DEVICE TO BE RETURNED. FEB 03 REQUEST FOR DEFECTIVE DEVICE TO BE RETURNED. CASE WAS CLOSED AS THERE WAS NO RESPONSE.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT # (B)(4). (B)(4) - 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. CUSTOMER REPLACED NVARM 2 WITH A SPARE AND THEY WERE REQUESTED TO RETURN THE DEFECTIVE DEVICE FOR INVESTIGATION.

    Description of Event or Problem · 0

    NICVIEW CAMERA STARTED TO SPARK AND SMOKE. THE NURSE UNPLUGED THE CAMERA AND BURNED HER HAND. THERE WAS A SPLIT IN ONE OF THE WIRES THAT COULD BE THE POTENTIAL CAUSE.

    Description of Event or Problem · 0

    NICVIEW CAMERA STARTED TO SPARK AND SMOKE. THE NURSE UNPLUGGED THE CAMERA AND BURNED HER HAND. THERE WAS A SPLIT IN ONE OF THE WIRES THAT COULD BE THE POTENTIAL CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2867199 NICVIEW 2.0 CAMERA CAMERA, TELEVISION, SURGICAL, WITH AUDIO FWC NATUS MEDICAL INCORPORATED NICVIEW 2.0 CAMERA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown