BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATUS PHOTIC STIM KIT

    MDR report key: 21177743 · Received January 17, 2025

    Report

    Report Number
    9612330-2025-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    December 1, 2024
    Report Date
    May 12, 2025
    Manufacturer
    NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD.
    Product Code
    GWE
    UDI-DI
    00382830015790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF TO NATUS COMPLAINT # (B)(4). INSTALL DATE OF DEVICE : SEP/30/2022 FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF TO NATUS COMPLAINT # (B)(4). REF. XLTEK PHOTIC STIMULATOR ON A ROLL STAND. REF. 10440 SERIAL NUMBER (B)(6). PER (B)(4) REV 78 EEG/PSG RISK ANALYSIS: HAZARD 6.1 - SHARP CORNER, EDGES OR PINCH POINTS. EFFECT (HARM): BRUISE / CONTUSION OR ABRASION RBA RATING: LOW. 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), 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. NO RELATED CAPAS. AS PER THE CUSTOMERS RESPONSE, THE CUSTOMER WILL NOT RETURN THE AFFECTED DEVICE FOR EVALUATION. BECAUSE THE CUSTOMER IS NOT ABLE TO RETURN THE DEVICE, NO FURTHER INVESTIGATION CAN BE MADE. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.

    Description of Event or Problem · 0

    NATUS PHOTIC STIM KIT - EEG TECH WAS ADJUSTING LIGHT WHEN HER SKIN GOT PINCHED BETWEEN THE TWO ARMS OF EQUIPMENT. 30 MINUTES IN THE ED GETTING FINGER STITCHED UP.

    Description of Event or Problem · 0

    NATUS PHOTIC STIM KIT - EEG TECH WAS ADJUSTING LIGHT WHEN HER SKIN GOT PINCHED BETWEEN THE TWO ARMS OF EQUIPMENT. 30 MINUTES IN THE ED GETTING FINGER STITCHED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141289 NATUS PHOTIC STIM KIT NATUS PHOTIC STIM KIT GWE NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. 003555 10440R9574 00382830015790

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other