BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV 2.X ARM

    MDR report key: 17844492 · Received September 29, 2023

    Report

    Report Number
    9612330-2023-00035
    Event Type
    Malfunction
    Date Received
    September 29, 2023
    Date of Event
    September 10, 2023
    Report Date
    November 22, 2023
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). SECTION D4. UDI NUMBER, SERIAL NUMBER IS NOT APPLICABLE. THE CUSTOMER HAS BEEN CONTACTED, AND REQUESTED TO RETURN THE AFFECTED PART FOR INVESTIGATION. THE ISSUE WAS ADDRESSED ON CAPA005355: "DESCRIPTION OF CHANGE: NICVIEW 2.0 - IMPROVEMENTS TO THE ARM HARDWARE (NVARM) FROM GCX TO ADDRESS DROOPING GOOSENECK FAILURES AND CAMERA MOUNTING SCREW (AT BALL SOCKET)." PER QMS-004442, COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER HAZARD ID LINE 6.7 IN (B)(4) NICVIEW 2 RISK ANALYSIS SPREADSHEET. SEVERITY RISK: 11; MODERATE. A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). VARIOUS REQUESTS WERE MADE TO GET THE PRODUCT RETURNED FOR EVALUATION. THE PART WAS RETURNED. DEPOT REPAIR STATED THAT THEY SCRAPPED THE DEVICE, AS THERE WAS NO NOTE THAT INDICATED IT NEEDED TO BE FURTHER INVESTIGATED. FAILURE CONFIRMED: NO. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.

    Description of Event or Problem · 0

    NV 2.X ARM: THE CUSTOMER REPORTED THAT THE ARM BECAME LOOSE AND CAUSED THE NV2 CAMERA ATTACHED TO DROOP AND NARROWLY MISSED A PATIENT. NO HARM TO PATIENT OR USER.

    Description of Event or Problem · 0

    NV 2.X ARM: THE CUSTOMER REPORTED THAT THE ARM BECAME LOOSE AND CAUSED THE NV2 CAMERA ATTACHED TO DROOP AND NARROWLY MISSED A PATIENT. NO HARM TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2287042 NV 2.X ARM NV 2.X ARM FWC NATUS MEDICAL INCORPORATED NVARM

    Patients

    Seq Age Sex Outcome Treatment
    1 0 MO Unknown