BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV 2.X ARM

    MDR report key: 14630040 · Received June 8, 2022

    Report

    Report Number
    9612330-2022-00038
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    May 4, 2022
    Report Date
    July 1, 2022
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). UDI NUMBER, SERIAL NUMBER IS NOT APPLICABLE. THE FLEX ARMS ON 15 CAMERAS HAVE LOST RIGIDITY WHICH PREVENTS THE CAMERA FROM FUNCTIONING AS INTENDED (CAMERA IS HELD UP TO VIEW THE BABY). NO PATIENTS WERE HARMED OR INVOLVED. A COMPANY REPRESENTATIVE WAS NOTIFIED BY HOSPITAL CLINICAL ENGINEERING DEPT. THE REPRESENTATIVE STATED THAT THERE IS NOTHING PLANNED AT THIS TIME TO PREVENT OR CORRECT THIS ISSUE DUE TO NO OTHER HOSPITALS THAT ARE EXPERIENCING THIS PROBLEM. THE CUSTOMER CONFIRMED "THEY KNOW "TWIST-TO-TIGHTEN" AND THEY CAN TELL SOME TENSION CHANGE BUT NONE WOULD SUPPORT THE CAMERA, IMMEDIATELY DROOPING AND EVENTUALLY POINTING ALMOST STRAIGHT-DOWN." NATUS SENT OUT THE REPLACEMENT PARTS TO THE CUSTOMER. ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER LINE 6.5 IN DOC-023354 NICVIEW 2.0 ANALYSIS 3 SPREADSHEET. NO DEATH OR SERIOUS INJURY, CONSIDERED A CUSTOMER INCONVENIENCE. 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. 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. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED. MEDWATCH FORM FDA 3500A WAS SUBMITTED BY THE CUSTOMER - REPORT# 3400690000-2022-8005. AWAITING FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# 10162160 NATUS WERE NOTIFIED THAT A MEDWATCH FORM FDA 3500A WAS SUBMITTED BY THE CUSTOMER - REPORT# (B)(4). PRODUCT RETURN WAS NOT REQUESTED FOR THE EVALUATION. LOW SAFETY RISK OF HARM, INDIVIDUAL COMPLAINT RELATED TO ISSUE STATED. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED. NO DEATH OR SERIOUS INJURY, CONSIDERED A CUSTOMER INCONVENIENCE.

    Description of Event or Problem · 0

    NV 2.X ARM THE FLEX ARMS ON 15 CAMERAS HAVE LOST RIGIDITY WHICH PREVENTS THE CAMERA FROM FUNCTIONING AS INTENDED (CAMERA IS HELD UP TO VIEW THE BABY). NO PATIENTS WERE HARMED OR INVOLVED. THE CUSTOMER CONFIRMED "THEY KNOW "TWIST-TO-TIGHTEN" AND THEY CAN TELL SOME TENSION CHANGE BUT NONE WOULD SUPPORT THE CAMERA, IMMEDIATELY DROOPING AND EVENTUALLY POINTING ALMOST STRAIGHT-DOWN." NO INJURIES REPORTED.

    Description of Event or Problem · 0

    NV 2.X ARM THE FLEX ARMS ON 15 CAMERAS HAVE LOST RIGIDITY WHICH PREVENTS THE CAMERA FROM FUNCTIONING AS INTENDED (CAMERA IS HELD UP TO VIEW THE BABY). NO PATIENTS WERE HARMED OR INVOLVED. THE CUSTOMER CONFIRMED "THEY KNOW "TWIST-TO-TIGHTEN" AND THEY CAN TELL SOME TENSION CHANGE BUT NONE WOULD SUPPORT THE CAMERA, IMMEDIATELY DROOPING AND EVENTUALLY POINTING ALMOST STRAIGHT-DOWN." NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227251 NV 2.X ARM NV 2.X ARM FWC NATUS MEDICAL INCORPORATED NVARM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown