BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMU40EXQ BREAKOUT BOX

    MDR report key: 19989570 · Received August 15, 2024

    Report

    Report Number
    9612330-2024-00042
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 27, 2024
    Report Date
    October 25, 2024
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWQ
    PMA / PMN Number
    K163163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT(B)(4). NO RELATED CAPA'S. THE CUSTOMER CONFIRMED THE AFFECTED PART WILL BE RETURNED FOR EVALUATION. PER DOC-010378 REV 72 RISK ANALYSIS SPREADSHEET (RAS) XLTEX EEG/PSG HAZARD ID 6.3, CAUSE - HIGH CHASSIS TEMPERATURE RESULTS IN BURN EFFECTS (HARM) - THIRD DEGREE BURN RISK LEVEL - MEDIUM THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN QMS-000018, HAZARDS THAT HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH KNOWN STANDARDS CAN BE PRESUMED TO BE CONSISTENT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF COMPLAINT# (B)(4). INSTALL DATE OF AFFECTED DEVICE WAS: 02 OCTOBER 2021 A DHR REVIEW IS NOT APPLICABLE BECAUSE, PRIOR TO THE REPORTED ISSUE THE DEVICE WAS IN SERVICE FOR 2 OR MORE YEARS AND A MANUFACTURING DEFECT IS VERY UNLIKELY. PRODUCT EXAMINATION AND FUNCTIONAL TESTING: INVESTIGATION RESULTS: PER ENGINEERING "PICTURES SENT SHOWED BROWN DRIED GEL AT THE POWER INPUT SIDE WHICH IS NOT A BURNT MATERIAL. THE UNIT WAS RECEIVED WITH A BURNT COMPONENT SMELL. THE UNIT WAS DELIVERED TO SERVICE REPAIR AND OPENED. AREA NEAR 3 POWER INPUT COILS ARE BURNT UP WHERE THE COVER WAS INTERNALLY BURNED. IT APPEARS THERE ARE TRACES OF GEL THROUGH THE COVER AND ONTO THE PCB. IT IS POSSIBLE THE GEL OR GEL AND CLEANING AGENT WAS CONDUCTIVE ENOUGH WHERE THE SOLUTION MAY HAVE BEEN CONDUCTIVE CAUSING MORE INRUSH CURRENT. FAILURE CONFIRMED: YES INVESTIGATION RESULT CODE: NEURO SBU/PHYSICAL DAMAGE COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.

    Description of Event or Problem · 0

    PART 028066 EMU40EXQ BREAKOUT BOX - DEVICE IS HEATING UP. THE ROOM SMELLED LIKE SMOKE, THE PART WAS EXTREMELY HOT TO TOUCH, THE GREY CORD MELTED. THERE WAS A BROWN BURNT SPOT ON THE POUCH. THE BREAKOUT RECORDED 16 HOURS BEFORE THE EVENT. NO INJURIES.

    Description of Event or Problem · 0

    PART 028066 EMU40EXQ BREAKOUT BOX - DEVICE IS HEATING UP. THE ROOM SMELLED LIKE SMOKE, THE PART WAS EXTREMELY HOT TO TOUCH, THE GREY CORD MELTED. THERE WAS A BROWN BURNT SPOT ON THE POUCH. THE BREAKOUT RECORDED 16 HOURS BEFORE THE EVENT. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177639 EMU40EXQ BREAKOUT BOX EMU40EXQ BREAKOUT BOX GWQ NATUS MEDICAL INCORPORATED 028066 028066030897

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown