BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NICVIEW 2.0 CAMERA

    MDR report key: 12077469 · Received June 28, 2021

    Report

    Report Number
    9612330-2021-00002
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 11, 2021
    Report Date
    October 22, 2021
    Product Code
    FWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). THE AFFECTED UNIT WAS RECEIVED INTO MIDDLETON. EXAMINATION AND TESTING WAS NOT PERFORMED BECAUSE FACTORY SERVICE DOES NOT SERVICE NICVIEW 2 PRODUCTS. CAPA005201 IS RELATED TO THIS COMPLAINT. CORECTIVE ACTION PLAN: NICVIEW 2.0 - IMPROVEMENT TO THE MICROUSB (POWER CABLE END) AT THE BASE OF THE NICVIEW 2 ARM. NICVIEW 2.0 - IMPROVEMENT TO THE MICROUSB (POWER CABLE) AT CAMERA END CREATED TO DESIGN PROTECTION FOR THE MICROUSBS. RISK ASSESSMENT WAS CONDUCTED AND RELEASED ON DOC-055534 REV 01 NICVIEW 2 MICRO-USB DAMAGE POST MARKET RISK ASSESSMENT. PREVENTIVE ACTION PLAN: INSTALL BRACKET, PN 036431, ON THE ARM USING SCREWS INSTEAD OF ADHESIVE AT THE MANUFACTURER. INVESTIGATION RESULT CODE: NEURO SBU/CONNECTOR DAMAGED. THIS COMPLAINT WAS VERIFIED, CAPA005201 ALREADY OPEN. BASED ON EVALUATION OF THIS COMPLAINT THERE IS NO SAFETY RISK OF HARM, INDIVIDUAL COMPLAINT RELATED TO ISSUE STATED. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED. PER (B)(4) COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. PER DOC-023354 LINE 2.2 SEVERITY 11- ACCEPTABLE RESIDUAL RISK LEVEL. 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. A SEARCH FOR SERVICE DATA THAT MAY HAVE BEEN RELEVANT TO THIS ISSUE WAS CONDUCTED. NO FURTHER INFORMATION RELATED TO THIS ISSUE WAS FOUND.

    Description of Event or Problem · 0

    DAMAGED CAMERA/PWRSUPPLY CONNECTION. (NICVIEW 2.0 CAMERA) SPARKS WHEN TRYING TO PLUG BACK IN. NO PATIENT INVOLEMENT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). CAM #3, MAC: B8:27:EB:65:4E:51, BROKEN CAMERA/PWRSUPPLY PORT SPARKS WHEN TRYING TO PLUG BACK. NO PATIENT INJURY. DAMAGED NVCAM RETURNING BACK TO MIDDLETON FOR EVALUATION.

    Description of Event or Problem · 1

    DAMAGED CAMERA/PWRSUPPLY CONNECTION. (NICVIEW 2.0 CAMERA) SPARKS WHEN TRYING TO PLUG BACK IN. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973687 NICVIEW 2.0 CAMERA NICVIEW 2.0 CAMERA FWC NVCAM

    Patients

    Seq Age Sex Outcome Treatment
    1