BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV 2.X ARM

    MDR report key: 15969550 · Received December 13, 2022

    Report

    Report Number
    9612330-2022-00053
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    October 25, 2022
    Report Date
    January 9, 2023
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT REF NATUS COMPLAINT# (B)(4). RELATED TO CAPA005355 - ISSUE PREVIOUSLY INVESTIGATED. PREVENTIVE ACTION - INSTALL BRACKET, PN 036431, ON THE ARM USING SCREWS INSTEAD OF ADHESIVE AT THE MANUFACTURER, GCX. ECR#20634 WAS RELEASED TO ADDRESS THIS. FAILURE CONFIRMED: YES. INVESTIGATION RESULT CODE: NEURO SBU/LOSS OF MECHANICAL INTEGRITY. CLOSURE RATIONALE: COMPLAINT VERIFIED, CAPA INITIATED OR ALREADY OPEN. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). UDI NUMBER, SERIAL NUMBER IS NOT APPLICABLE. THE CUSTOMER REPORTED AN ISSUE WITH MULTIPLE ARMS NOT STAYING SUSPENDED. CUSTOMER REPORTED THAT 2 CAMERA ARMS HAD FALLEN ON 2 DIFFERENT BABIES. NO INJURY REPORTED. NO DELAY IN TREATMENT. PER (B)(4) - NICVIEW 2.0 RISK ANALYSIS HAZARD ID 6.7, SEVERITY 11-CRITICAL, THE RISK IS CONSIDERED MODERATE. 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. REFER TO SECTION 1.1.1 OF 028158 : INSTRUCTIONS FOR USE, NICVIEW 2. - 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. RELATED TO (B)(4) - ISSUE PREVIOUSLY INVESTIGATED. 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. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    PART NVARM - NV 2.X ARM - THE CUSTOMER REPORTED AN ISSUE WITH MULTIPLE ARMS NOT STAYING SUSPENDED. NO INJURY REPORTED. NO DELAY IN TREATMENT.

    Description of Event or Problem · 0

    PART NVARM - NV 2.X ARM - THE CUSTOMER REPORTED AN ISSUE WITH MULTIPLE ARMS NOT STAYING SUSPENDED. NO INJURY REPORTED. NO DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386737 NV 2.X ARM NV 2.X ARM FWC NATUS MEDICAL INCORPORATED NVARM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown