BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATUS BRAIN MONITOR BREAKOUT

    MDR report key: 17422888 · Received July 31, 2023

    Report

    Report Number
    9612330-2023-00020
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Date of Event
    June 28, 2023
    Report Date
    August 23, 2023
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWQ
    UDI-DI
    00382830047241
    PMA / PMN Number
    K180290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT#(B)(4). A NATUS SPECIALIST WENT ONSITE AND CHECKED EACH HEADBOX AND FOUND THAT ALL REMOVABLE HANDLES ARE INTACT WITHOUT RIPS OR TEARS. CAPA004628. WAS PREVIOUSLY OPENED TO INVESTIGATE LOOSE HANDLES. SERIAL NUMBER NOT PROVIDED. PER DOC-010378 XLTEK EEG PSG RISK ANALYSIS SPREADSHEET, HAZARD ID - 6.10, 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. 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. FAILLURE CONFIRMED: NO INVESTIGATION RESULT CODE: NEURO SBU/NO ISSUES NOTED CLOSURE RATIONALE: COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). THE CUSTOMER RETURNED A COMPETED ADVERSE EVENT QUESTIONNAIRE. PER THE CUSTOMER, THE PATIENT ROLLED OVER IN THE MIDDLE OF THE NIGHT AND PULLED ON THE WIRES CAUSING THE BREAKOUT BOX TO FALL ON HIS HEAD. ONE SIDE OF THE RUBBER LOOP AT THE TOP OF THE BOX CAME OUT SO THE BOX FELL FROM ITS HOOK. THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY AND NO MEDICAL INTERVENTION WAS NEEDED. THE CUSTOMER STATES THAT THE BREAKOUT BOX IS NOT BROKEN BUT CAN BE RETURNED IF REQUESTED. PER DOC-010378 XLTEK EEG PSG RISK ANALYSIS SPREADSHEET, HAZARD ID - 6.12, SEVERITY 11 - CRITICAL, THE RISK IS CONSIDERED MODERATE. INSTALL DATE: (B)(6) 2023. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    PART 021920 NATUS BRAIN MONITOR BREAKOUT - THE DOCTOR CONFIRMED THAT THE PATIENT MOVED, PULLED OUT THE WIRES, AND THE BREAKOUT BOX FELL ON HIM. NO INJURIES.

    Description of Event or Problem · 0

    PART 021920 NATUS BRAIN MONITOR BREAKOUT - THE DOCTOR CONFIRMED THAT THE PATIENT MOVED, PULLED OUT THE WIRES, AND THE BREAKOUT BOX FELL ON HIM. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813721 NATUS BRAIN MONITOR BREAKOUT NATUS BRAIN MONITOR BREAKOUT GWQ NATUS MEDICAL INCORPORATED 021920 00382830047241

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Other