BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURBISHED WIRED SECURITY CAMERA - (NV1)

    MDR report key: 17610153 · Received August 24, 2023

    Report

    Report Number
    9612330-2023-00031
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    August 17, 2023
    Report Date
    October 17, 2023
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). INVESTIGATION RESULTS: THE RETURNED BRACKET WAS BROKEN AT THE POINT THAT THE SHEET METAL BRACKET IS MOUNTED TO THE ARM. THE HALF-CIRCLE PORTION OF THE BRACKET THAT CLAMPS TO THE END OF THE ARM WAS SEPARATED FROM THE SHEET METAL PORTION OF THE BRACKET. THERE ARE TWO WELDS ATTACHING THE HALF-CIRCLE PORTION OF THE BRACKET TO THE SHEET METAL PORTION. BOTH WELDS HAD FAILED. THERE WAS SOME SURFACE RUST VISIBLE ON THE SURFACES BETWEEN THE TWO PORTIONS OF THE CLAMP. THIS SURFACE RUST DOES NOT APPEAR TO HAVE AFFECTED THE WELDS. THE BRACKET IS BUILT BY WELDING THE TWO PARTS OF THE BRACKET TOGETHER AND THEN THERE IS A PLATING PROCESS TO GIVE THE FINISHED BRACKET A BRIGHT METAL FINISH RESISTANT TO RUST. THE PLATING PROCESS WILL NOT GET IN BETWEEN THE TWO PARTS AND SO THE AREA IN BETWEEN THE PARTS IS NOT PLATED. THIS IS WHY THE AREA BEHIND THE HALF-CIRCLE PORTION OF THE BRACKET LOOKS DIFFERENT AND IS SUSCEPTIBLE TO THE SURFACE RUST THAT IS SEEN. AN INFORMAL TEST OF ANOTHER BRACKET WAS CARRIED OUT TO SEE HOW MUCH FORCE IT TAKES TO REMOVE THE HALF-CIRCLE PORTION FROM THE SHEET METAL PORTION TO DUPLICATE THE FAILURE SEEN IN THE FIELD. IT TOOK SIGNIFICANT FORCE TO REMOVE THE HALF-CIRCLE PORTION OF THE BRACKET, SO MUCH THAT THE 0.125" THICK STEEL BRACKET WAS SIGNIFICANTLY BENT. THIS APPEARS TO BE AN ISOLATED CASE OF WEAK WELDS THAT DID NOT PENETRATE SUFFICIENTLY INTO THE HALF-CIRCLE PORTION OF THE BRACKET AS THE MAJORITY OF THE WELD MATERIAL REMAINS ON THE SHEET METAL PORTION OFF THE BRACKET. ROOT CAUSE/PROBABLE ROOT CAUSE: THE ROOT CAUSE APPEARS TO BE WEAK WELDS BETWEEN THE TWO PARTS. THIS MAY BE CAUSED BY A NUMBER OF FACTORS INCLUDING IMPROPER SURFACE PREPARATION OR INSUFFICIENT WELD PENETRATION. RECOMMENDED ACTIONS: BASED ON THE UNIQUE FAILURE MODE AND THE RELATIVELY SAFE FAILURE MODE (IF THE BRACKET FAILS THE CAMERA WILL FALL A FEW INCHES AND WEIGHS LESS THAN POUND) NATUS WILL CONTINUE TO MONITOR FOR THIS TYPE OF FAILURE BUT IT WOULD BE MORE FOR PROCESS/PRODUCT IMPROVEMENT THAN A SAFETY CONCERN. FAILURE CONFIRMED: YES . CLOSURE RATIONALE: COMPLAINT VERIFIED, ISOLATED INCIDENT AND MONITOR FOR FUTURE OCCURRENCE. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4) . TECHNICAL SUPPORT REQUESTED CUSTOMER TO RETURN ENTIRE CAMERA SYSTEM AND PROVIDED SHIPPING LABEL. THEY ALSO PROVIDED THE IFU NICVIEW MANUAL TO CUSTOMER AND REQUESTED THEY REVIEW THE SAFETY INTENDED USE INSTRUCTIONS WITH STAFF. IFU SHOWS WARNING TO "NEVER MOUNT DIRECTLY OVER A BABY" 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 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 AS PER HAZARD ID B1 IN DOC-019388 RISK ANALYSIS FOR NICVIEW. RISK IS CONSIDERED TO BE LOW. SEVERITY LEVEL 3. 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." UDI#: NOT APPLICABLE SHIP DATE: (B)(6) 2023. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    CUSTOMER REPORTS METAL BRACKET BROKE IN TWO LEAVING CAMERA HANGING BY THE CABLE ABOVE PATIENT BED. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    CUSTOMER REPORTS METAL BRACKET BROKE IN TWO LEAVING CAMERA HANGING BY THE CABLE ABOVE PATIENT BED. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251499 REFURBISHED WIRED SECURITY CAMERA - (NV1) REFURBISHED WIRED SECURITY CAMERA - (NV1) FWC NATUS MEDICAL INCORPORATED CAM-002R

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown