BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NICVIEW 2.0 (NV 2.X ARM)

    MDR report key: 12655812 · Received October 19, 2021

    Report

    Report Number
    9612330-2021-00033
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    September 24, 2021
    Report Date
    August 29, 2022
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER LINE 6.7 IN DOC-(B)(4) NICVIEW 2 RISK ANALYSIS. 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 PROBABLY 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. TECHNICAL SERVICE HAVE SENT A AE QUESTIONNAIRE TO THE CUSTOMER. THE AFFECTED PRODUCT HAS BEEN REQUESTED FOR RETURN FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 REF NATUS COMPLAINT#(B)(4). SEVERAL ATTEMPTS WERE MADE TO THE CUSTOMER FOR THE DEFECTIVE PARTS TO BE RETURNED. PRODUCT WAS NOT RETURNED FOR FURTHER EVALUATION, THEREFORE UNABLE TO VERIFY COMPLAINT. ADDITIONAL INFORMATION REGARDING THIS COMPLAINT IS DOCUMENTED UNDER CAPA005201. RISK IS CONSIDERED LOW. INITIAL REPORT IS NOT RELATED TO PATIENT/USER SAFETY. CLOSURE RATIONALE: COMPLAINT COULD NOT BE VERIFIED, MATERIALS NOT RETURNED FOR ANALYSIS. NO DEATH OR SERIOUS INJURY, CONSIDERED A CUSTOMER INCONVENIENCE. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR NICVIEW 2.0 CAMERA ARM IS NO LONGER ABLE TO HOLD ITS UPRIGHT POSITION AND KEEPS FALLING DOWN. THERE WAS NO PATIENT INVOLVED IN THIS INCIDENT. THERE WAS NO DEATH OR SERIOUS INJURY THAT REQUIRED MEDICAL TREATMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR NICVIEW 2.0 CAMERA ARM IS NO LONGER ABLE TO HOLD ITS UPRIGHT POSITION AND KEEPS FALLING DOWN. THERE WAS NO PATIENT INVOLVED IN THIS INCIDENT. THERE WAS NO DEATH OR SERIOUS INJURY THAT REQUIRED MEDICAL TREATMENT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT REF NATUS COMPLAINT # (B)(4). NO UDI RECORDED AS THIS IS NOT APPLICABLE FOR THIS DEVICE. THE AFFECTED PRODUCT HAS BEEN REQUESTED FOR RETURN FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR NICVIEW 2.0 CAMERA ARM IS NO LONGER ABLE TO HOLD ITS UPRIGHT POSITION AND KEEPS FALLING DOWN. THERE WAS NO PATIENT INVOLVED IN THIS INCIDENT. THERE WAS NO DEATH OR SERIOUS INJURY THAT REQUIRED MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558143 NICVIEW 2.0 (NV 2.X ARM) NICVIEW 2.0 (NV 2.X ARM) FWC NATUS MEDICAL INCORPORATED NVARM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown