BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NICVIEW FLEXIBLE ARM ASSEMBLY (39.5" = 100CM) CE

    MDR report key: 19286935 · Received May 10, 2024

    Report

    Report Number
    9612330-2024-00024
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    April 23, 2024
    Report Date
    October 7, 2024
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 REF NATUS COMPLAINT#(B)(4). CORRECTION TO DEVICE NAME, MODEL, AND ADDED SERIAL NUMBER REFERENCE TO SECTIONS D1, D2A, D4. INVESTIGATION RESULTS: THE ARM MOUNTING SHAFT WAS RETURNED WITH THE MOUNTING CLAMP. THE PORTION OF THE MOUNTING SHAFT THAT BROKE OFF WAS RETAINED INSIDE OF THE MATING COMPONENT ON THE CLAMP. THERE IS A SECTION WITH A SMALLER DIAMETER ON THE MOUNTING SHAFT TO ALLOW A SCREW TO BE USED TO RETAIN THE SHAFT IN THE MOUNTING CLAMP. THE MOUNTING SHAFT BROKE AT THE AREA WHERE THE SHAFT REDUCES TO THE SMALLER DIAMETER. THE GEOMETRY OF THE MOUNTING SHAFT WOULD MAKE THIS THE POINT WHERE STRESS IS CONCENTRATED FROM THE WEIGHT OF THE ARM ON THE SHAFT. ROOT CAUSE/PROBABLE ROOT CAUSE: IF THE ARM WAS UNDER A STATIC LOAD IT WOULD LIKELY NEVER FAIL, HOWEVER IT'S COMMON FOR THE ARM TO BE ADJUSTED WITHOUT COMPLETELY LOOSENING THE JOINT PRIOR TO MOVING IT, BUMPING INTO THE ARM WHILE MOVING THE ARM OR MOVING AROUND THE ARM,ETC. IT IS LIKELY THAT OVER TIME THE ARM WAS EXPOSED TO DYNAMIC LOADING HIGHER THAN STANDARD USAGE THAT WOULD LEAD TO INCREASED STRESS AND METAL FATIGUE THAT COULD START WITH A CRACK IN THE MATERIAL AND EVENTUALLY THE CRACK WOULD PROPAGATE AND CAUSE THE PART TO FAIL. RECOMMENDED ACTIONS: IF THE CUSTOMER IS FOLLOWING THE IFU THE ARM/CAMERA SHOULD NEVER BE POSITIONED OVER A PATIENT AND THERE SHOULD NEVER BE A RISK OF AN ARM FALLING AND CAUSING AN INJURY IF THIS TYPE OF FAILURE WERE TO RECUR. THIS IS A KNOWN ISSUE AND THIS ARM IS BEING PHASED OUT. INVESTIGATOR COMPLETION DATE: 24-SEP-2024 FAILURE CONFIRMED:YES INVESTIGATION RESULT CODE: MECHANICAL FAILURE.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT#(B)(4). THE SUSPECTED DEVICE PART NUMBER WAS CONFIRMED AND WAS ENTERED INTO SECTION D4. UDI# IS NOT APPLICABLE. PER (B)(4) REV B RISK ANALYSIS FOR NICVIEW. HAZARD ID B1 SUPPORT FAILURE. HAZARDOUS SITUATIONS - THE SUPPORT FAILS TO SUPPORT ARM & CAMERA FALLS ON THE PATIENT. UNIT USED ON AN INFANT WARMER. HARM - PATIENT INJURY. RATING - LOW. NO RELATED CAPAS. CURRENTLY WAITING FOR THE AFFECTED PART TO BE RETURNED FOR EVALUALTION.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT#(B)(4). SECTION D4 TO BE COMPLETED ONCE THIS INFORMATION IS AVAILABLE. NO INJURIES REPORTED. A QUESTIONNAIRE WAS SENT TO THE CUSTOMER IN ORDER TO OBTAIN MORE INFORMATION. AWAITING RESPONSE. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    ARM BROKEN - THE BASE PINS ON THE NICVIEW ARM SNAPPING AND NEARLY FALLING ONTO A BABY. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    ARM BROKEN - THE BASE PINS ON THE NICVIEW ARM SNAPPING AND NEARLY FALLING ONTO A BABY. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    ARM BROKEN - THE BASE PINS ON THE NICVIEW ARM SNAPPING AND NEARLY FALLING ONTO A BABY. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879068 NICVIEW FLEXIBLE ARM ASSEMBLY (39.5" = 100CM) CE NICVIEW FLEXIBLE ARM ASSEMBLY (39.5" = 100CM) CE FWC NATUS MEDICAL INCORPORATED ARM-004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown