BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV 2.X ARM

    MDR report key: 19508291 · Received June 11, 2024

    Report

    Report Number
    9612330-2024-00032
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    May 29, 2024
    Report Date
    November 19, 2024
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT#(B)(4). SECTION D4. UDI# AND LOT NUMBER NOT APPLICABLE. A QUESTIONNAIRE HAS BEEN SENT TO THE CUSTOMER FOR MORE DETAILS AND A REPLACEMENT PART WAS SENT TO THE CUSTOMER. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT#: (B)(4). PER (B)(4) REV J NICVIEW 2.0 RISK ANALYSIS SPREADSHEET (RAS) HAZARD ID 6.7 - ARM ASSEMBLY FAILS DUE TO EXCESSIVE STATIC LOADS OR WEAR AND SAGS EFFECTS (HARM) - INJURY TO USER, PATIENT OR LOSS OF FUNCTION DUE MISFRAMED VIDEO. THE HAZARDS IDENTIFIED HAVE RBA RATING OF LOW AND ARE DEEMED BROADLY ACCEPTABLE. THESE RISKS HAVE BEEN REVIEWED TO DETERMINE IF ANY FURTHER CONTROL MEASURES MAY BE IMPLEMENTED SO AS TO FURTHER REDUCE THE RISK AS FAR AS POSSIBLE. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. NO RELATED CAPAS. INVESTIGATION RESULTS: DEFECTIVE CAMERA WAS RETURNED WITHOUT THE ALLEGED DEFECTIVE ARM, UNABLE TO COMPLETE EVALUATION. NO ADDITIONAL PICTURES PROVIDED TO CONFIRM THE FAILURE. ROOT CAUSE/PROBABLE ROOT CAUSE: KNOWN ISSUE - NVARM IS PHASED OUT AND IT IS BEING REPLACED BY NVARM2.

    Description of Event or Problem · 0

    PART NVARM - ARM IS DROOPY AND STRUCK A NURSE IN THE HEAD.

    Description of Event or Problem · 0

    PART NVARM: ARM IS DROOPY AND STRUCK A NURSE IN THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802540 NV 2.X ARM NV 2.X ARM FWC NATUS MEDICAL INCORPORATED NVARM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown