BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NICVIEW 2.0

    MDR report key: 23485726 · Received November 6, 2025

    Report

    Report Number
    9612197-2025-00008
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    October 28, 2025
    Report Date
    December 10, 2025
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT # (B)(4). REPLACEMENT NVARM2 SHIPPED TP CUSTOMER (B)(6) 2025 (B)(4). DEFECTIVE PART REQUESTED FOR RETURN (B)(6). DEFECTIVE PART REQUESTED FOR RETURN (B)(6). DEFECTIVE PART REQUESTED FOR RETURN (B)(6). THE CUSTOMER NEVER RETURNED THE DEFECTIVE PART BACK; NO INVESTIGATION COULD BE CARRIED OUT. RISK MANAGEMENT FILE REVIEW: DOC-023354 REV B - RISK ANALYSIS FOR NICVIEW 2.0 HAZARD 6.7. CAUSE - ARM ASSEMBLY FAILS DUE TO EXCESSIVE STATIC LOADS OR WEAR AND SAGS. EFFECT - SYSTEM FALL. RESIDUAL RISK - MODERATE. SEVERITY - 11. 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.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT # (B)(4). REPLACEMENT NVARM 2 SHIPPED TO CUSTOMER 4 NOV 2025 ((B)(4)) DEFECTIVE PART REQUESTED FOR RETURN.

    Description of Event or Problem · 0

    THE CAMERA WASN'T FUNCTIONING, SO THE EMPLOYEE DISCONNECTED AND CONNECTED/ PLUGGED IT BACK IN. AFTER, THE CAMERA SWUNG DOWN AND HIT HER ON THE BACK.

    Description of Event or Problem · 0

    THE CAMERA WASN'T FUNCTIONING, SO THE EMPLOYEE DISCONNECTED AND CONNECTED / PLUGGED IT BACK IN. AFTER, THE CAMERA SWUNG DOWN AND HIT HER ON THE BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2552146 NICVIEW 2.0 NICVIEW 2.0 FWC NATUS MEDICAL INCORPORATED NVARM2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown