BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRED SECURITY CAMERA (WEB ENABLED)

    MDR report key: 14490117 · Received May 24, 2022

    Report

    Report Number
    9612330-2022-00029
    Event Type
    Malfunction
    Date Received
    May 24, 2022
    Date of Event
    October 4, 2020
    Report Date
    June 16, 2022
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). CUSTOMER REPORTED THE NICVIEW CAMERA FELL FROM THE SUPPORT "POLE" AND LANDED CLOSE TO THE PATIENT. NO INJURY REPORTED AND NO DELAY IN TREATMENT REPORTED. FORWARDED AE QUESTIONNAIRE AND REQUEST FOR PICTURES TO CUSTOMER. DEVICE HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION. CUSTOMER RESPONSE TO QUESTIONNAIRE ATTACHED. DATE OF THE EVENT WAS (B)(6) 2020. UNSURE IF IT WAS THE INITIAL USE OF DEVICE. ASKED TECHNICAL SERVICE TO REQUEST PICTURES OF MALFUNCTION AS NONE WERE PROVIDED BY CUSTOMER. CUSTOMER SENT E-MAIL WITH 3 PICTURES OF DAMAGED ARM AND CAMERA. CUSTOMER CONFIRMED THE EQUIPMENT HAD BEEN TAKEN OUT OF USE AFTER THE INCIDENT OCCURRED ON (B)(6) 2020. PER HAZARD ID B2 OF DOC-019388 - RISK ANALYSIS FOR NICVIEW, THE RISK IS CONSIDERED MODERATE. UDI#: NOT APPLICABLE. AFFECTED PART RECEIVED AND SENT TO ENGINEERING FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT REF NATUS COMPLAINT# (B)(4). INVESTIGATION RESULTS: ARM AND CAMERA WERE RETURNED FOR INVESTIGATION. NO DAMAGE SEEN TO THE CAMERA THREADED INSERT OR PLASTIC HOUSING EXCEPT FOR SOME LIGHT SCUFFING ON THE PLASTIC HOUSING NEAR THE THREADED INSERT WHICH WOULD INDICATE THE CAMERA RUBBING AGAINST THE MOUNTING BRACKET ON THE ARM IF THE SECURING SCREW WAS LOOSE FOR SOME TIME. CAMERA HAS A LABEL WITH "08" MATCHING THE PICTURES SUPPLIED BY THE CUSTOMER. NO DAMAGE SEEN TO THE MOUNTING BRACKET ON THE END OF THE ARM WHERE THE CAMERA MOUNTS. THREE PICTURES WERE SUPPLIED BY THE CUSTOMER. THE FIRST PICTURE SHOWS THE END OF THE ARM WITH THE SCREW VISIBLE IN THE SLOT, AND THE CAMERA IS NOT MOUNTED TO THE ARM. THE SECOND PICTURE SHOWS A CAMERA MOUNTED TO THE ARM WITH A WASHER ON THE SCREW. POSSIBLY THE CUSTOMER TOOK A PICTURE OF ANOTHER ARM WITH A CAMERA THAT HAD NOT COME LOOSE. THE THIRD PICTURE SHOWS THE CAMERA ON A TABLE TOP, NOT MOUNTED TO THE ARM. THE COMPLAINT ALSO SAYS "CAMERA (#8) HEAD FELL OFF THE POLE AND ALMOST STRUCK AN INFANT IN THE FACE. LOOKS LIKE THERE IS A MISSING SCREW. " THE CAMERAS ARE NEVER TO BE POSITIONED OVER AN INFANT PER THE IFU SO EVEN IF SOMETHING WERE TO FAIL A PATIENT WOULD NOT BE IN DANGER. ALSO THE POWER CABLE AND NETWORK CABLE WOULD BE PLUGGED INTO THE CAMERA. THE NETWORK CABLE HAS A LOCKING CONNECTOR AND THE CAMERA WOULD FALL APPROXIMATELY 6 INCHES BEFORE BEING SUPPORTED BY THE CABLES. ROOT CAUSE/PROBABLE ROOT CAUSE: SCREW HOLDING THE CAMERA CAME LOOSE AND FELL OUT CAUSING THE CAMERA TO COME DETACHED FROM THE END OF THE ARM. RECOMMENDED ACTIONS: MONITOR FOR TRENDING, POSSIBLE SOLUTIONS WOULD BE PREVENTATIVE MAINTENANCE IF A CAMERA WAS NOTICED TO BE LOOSE ON THE END OF THE ARM OR ADDITION OF A THREAD LOCKING AGENT TO THE THREADS OF THE SCREW. THERE ARE NO CAPA'S RELATED TO THIS ISSUE. THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. 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. FAILURE CONFIRMED: YES. INVESTIGATION RESULT CODE: NEURO SBU/LOOSE COMPONENT. CLOSURE RATIONALE: COMPLAINT VERIFIED, ISOLATED INCIDENT AND MONITOR FOR FUTURE OCCURRENCE. 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.

    Description of Event or Problem · 0

    WIRED SECURITY CAMERA (WEB ENABLED) - CAMERA FELL OFF ARM AND LANDED CLOSE TO THE PATIENT. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    WIRED SECURITY CAMERA (WEB ENABLED) - CAMERA FELL OFF ARM AND LANDED CLOSE TO THE PATIENT . NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2806831 WIRED SECURITY CAMERA (WEB ENABLED) WIRED SECURITY CAMERA (WEB ENABLED) FWC NATUS MEDICAL INCORPORATED CAM-002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown