BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMU40EX BASE UNIT

    MDR report key: 10756947 · Received October 29, 2020

    Report

    Report Number
    9612330-2020-00012
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    September 29, 2020
    Report Date
    October 1, 2020
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2020. REFERENCE (B)(4). THE UNIT AND AFFECTED COMPONENTS HAVE BEEN REQUESTED TO BE RETURNED BACK TO MIDDLETON FOR PRODUCT INVESTIGATION.

    Additional Manufacturer Narrative · 0

    21 JANUARY 2021 REF SR# (B)(4). THE CUSTOMER REPORTED THE DEFECTIVE UNIT IS OVERHEATING AND MELTED. 1) NO DEATH OR SERIOUS INJURY CAUSED. 2) NO BURNING SMELL OR EVIDENCE OF BURNING ON THE DEVICE. 3) THE DEVICE WAS BEING USED FOR PATIENT CARE AT THE TIME OF THE EVENT. 4) THE DEVICE DID NOT HAVE CONTACT WITH ANOTHER HOT OBJECT WHICH COULD HAVE CAUSED THE EMU40EX CHASSIS TO MELT. PRODUCT EXAMINATION AND FUNCTIONAL TESTING: INVESTIGATION RESULTS/REPAIR NOTES - STUDY RUNNING FOR 72 HOURS THIS UNIT DID NOT GET HOT DURING THE STUDY RUNNING. IT FELT LITTLE WARM BUT THIS IS NORMAL. NO FAULT FOUND AND NO USER/PATIENT WAS INJURED. DEVICE COMPLIES WITH (B)(4) STANDARDS AND SINCE THE ENCLOSURE IS UL-94 CERTIFIED AND THE PRINTED CIRCUIT BARE BOARD MATERIAL IS FR4 AND QUALIFIED UNDER UL 94. THERE IS NO RISK OF THE DEVICE IGNITING, OR CAUSING HARM TO THE USER/PATIENT. PER HAZARD ID 6.3 OF DOC-010378 EEG/PSG RISK ANALYSIS THE RISK IS LOW - 3. INVESTIGATION RESULT CODE: NEURO SBU/NO ISSUES NOTED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED PART OVER HEATED AND WAS HOT TO TOUCH. NO PATIENT INJURY.

    Description of Event or Problem · 0

    CUSTOMER REPORTED PART OVER HEATED AND WAS HOT TO TOUCH.

    Additional Manufacturer Narrative · 1

    (B)(6) 2020 REFERENCE SR#1-740234502. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PART OVER HEATED AND WAS HOT TO TOUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224661 EMU40EX BASE UNIT EMU40EX BASE UNIT GWQ NATUS MEDICAL INCORPORATED 006550

    Patients

    Seq Age Sex Outcome Treatment
    1