BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV 2.X ARM

    MDR report key: 15377218 · Received September 8, 2022

    Report

    Report Number
    9612330-2022-00041
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    August 11, 2022
    Report Date
    November 4, 2022
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT FOR COMPLAINT (B)(4). WAITING FOR CUSTOMER TO IDENTIFY THE INVOLVED CAMERA/ARM. TECHNICAL SERVICE HAVE MADE SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER. THEY HAVE PROVIDED THEM WITH THE QUESTIONNAIRE AND ARE AWAITING FEEDBACK. RISK MANAGEMENT FILE REVIEW (PRODUCT AND EVENT). THE CURRENT RISK FILE DOC-023354 REV H NICVIEW 2 RISK ANALYSIS HAZARD ID 6.7 IDENTIFIES THIS ISSUE .HARM INJURY TO USER, PATIENT OR LOSS OF FUNCTION DUE MISFRAMED VIDEO. CAUSE ARM ASSEMBLY FAILS DUE TO EXCESSIVE STATIC LOADS OR WEAR AND SAGS .SEVERITYCRITICAL (11). RISK LEVEL MODERATE (11). FEEDBACK PROVIDED BY LEAD RISK MANAGMENT ENGINEER WITH REFERENCE TO THE RELATED IFU THAT IT STATES IFU INSTRUCTS THE DISTANCE OF THE CAMERA FROM THE BED SPACE WHEN USING A RADIANT WARMER SHOULD BE A MINIMUM OF 1.5 FEET, AND DISTANCE OF THE CABLES FROM BED SPACE A MINIMUM OF 2 FEET. IFU INSTRUCTS USER TO NEVER MOUNT CAMERA OVER A BABY IN AN OPEN BED SPACE. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT FOR COMPLAINT (B)(4). PRODUCT RETURN WAS NOT RETURNED FOR THE EVALUATION. LOW SAFETY RISK OF HARM, INDIVIDUAL COMPLAINT RELATED TO ISSUE STATED. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED. NO DEATH OR SERIOUS INJURY, CONSIDERED A CUSTOMER INCONVENIENCE. UDI: N/A. CAPA005355 RELATES TO THIS ISSUE. FAILLURE CONFIRMED?:NO. INVESTIGATION RESULT CODE (N/A TO ALL QMS):NEURO SBU/PRODUCT NOT RETURNED. CLOSURE RATIONALE:COMPLAINT VERIFIED, CAPA INIATED OR ALREADY OPEN.

    Description of Event or Problem · 0

    CUSTOMER REPORTS THEY ARE HAVING MANY ISSUES WITH ARMS "FALLING" AND NOT STAYING UP. THEY HAD ONE ISSUE WITH THE CAMERA COMING DOWN ON A BABY. CAMERA DID NOT ACTUALLY TOUCH THE BABY, IT GOT DOWN CLOSE TO THE BABY'S FACE. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    CUSTOMER REPORTS THEY ARE HAVING MANY ISSUES WITH ARMS "FALLING" AND NOT STAYING UP. THEY HAD ONE ISSUE WITH THE CAMERA COMING DOWN ON A BABY. CAMERA DID NOT ACTUALLY TOUCH THE BABY, IT GOT DOWN CLOSE TO THE BABY'S FACE. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234367 NV 2.X ARM NV 2.X ARM FWC NATUS MEDICAL INCORPORATED NVARM

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose