BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV 2.X ARM

    MDR report key: 17248482 · Received July 3, 2023

    Report

    Report Number
    9612330-2023-00014
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    June 26, 2023
    Report Date
    July 19, 2023
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). SECTION D4. UDI NUMBER, SERIAL NUMBER IS NOT APPLICABLE. WAITING FOR THE CUSTOMER TO FILL OUT THE ADVERSE EVENT QUESTIONNAIRE. WE HAVE ALSO REACHED OUT TO THE CUSTOMER TO CONFIRM IF THE AFFECTED PRODUCT WILL BE RETURNED FOR EVALUATION. PICTURES WERE ALSO REQUESTED IF AVAILABLE. ACCEPTABLE RISK AS PER HAZARD ID 6.6 IN DOC-023354 NICVIEW 2 RISK ANALYSIS. RISK IS CONSIDERED TO BE MODERATE. 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. RELATED CAPA - REFERENCE CAPA005355 FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). THE CUSTOMER PROVIDED CONFIRMATION IN FOLLOW UP EMAIL, THAT THE CAMERA DID NOT FALL OFF OF THE ARM: THE CAMERA REMAINED ATTACHED TO THE ARM, BUT THEY WERE UNABLE TO TIGHTEN THE CAMERA INTO PLACE AT THE BALL JOINT OF THE ARM. THE SCREW THAT TYPICALLY HOLDS THE BALL JOINT IN POSITION CONTINUED TO TURN, WITHOUT EVER TIGHTENING THE BALL JOINT INTO PLACE. THIS MADE THE CAMERA FLOP DOWN, MAKING IT IMPOSSIBLE TO POSITION ON THE BABY. A PATIENT WAS NOT INJURED OR AT RISK OF INJURY FROM THIS ARM OR CAMERA. 05-JUL-2023: INFORMATION RECEIVED FROM THE CUSTOMER, CONFIRMED ARM WAS DISPOSED OF. UNABLE TO RETURN FOR EVALUATION. THE FAILURE WAS NOT CONFIRMED. THE COMPLAINT COULD NOT BE VERIFIED, MATERIALS NOT RETURNED FOR ANALYSIS. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.

    Description of Event or Problem · 0

    PART NVARM - BALL JOINT DOES NOT STAY TIGHT, CAMERA FALLS. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    PART NVARM - BALL JOINT DOES NOT STAY TIGHT, CAMERA FALLS. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26677 NV 2.X ARM NV 2.X ARM FWC NATUS MEDICAL INCORPORATED NVARM

    Patients

    Seq Age Sex Outcome Treatment
    1 0 MO Unknown Other