BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMU40EX BREAKOUT BOX

    MDR report key: 20891792 · Received December 10, 2024

    Report

    Report Number
    9612330-2024-00049
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    August 1, 2024
    Report Date
    March 14, 2025
    Manufacturer
    NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD.
    Product Code
    GWQ
    PMA / PMN Number
    K9612330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF TO NATUS COMPLAINT # (B)(4). UPDATED SECTION B5., DESCRIPTION OF EVENT. UPDATED SECTIONS D1., D2(A)., D2(B)., AND D4. IN RELATION TO DETAILS OF THE SUSPECTED MEDICAL DEVICE. PER (B)(4) REV 80 EEG/PSG RISK ANALYSIS: HAZARD 5.11 - LOSS OF CONNECTION BETWEEN AMPLIFIER AND PC PREVENTS PC FROM RECEIVING AND RECORDING DATA. EFFECT (HARM): DELAYED DIAGNOSIS - WITH NO CLINICAL EFFECTS. THE HAZARDS IDENTIFIED HAVE RBA RATING OF NEGLIGIBLE AND ARE DEEMED BROADLY ACCEPTABLE. THESE RISKS HAVE BEEN REVIEWED TO DETERMINE IF ANY FURTHER CONTROL MEASURES MAY BE IMPLEMENTED SO AS TO FURTHER REDUCE THE RISK AS FAR AS POSSIBLE. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. PART 006562 SN (B)(6) WAS EXCHANGED ON A RELATED NATUS COMPLAINT# (B)(4) AND WAS RETURNED ON THE 07TH OF NOV 2024. THE DEVICE WAS EVALUATED AND DEPOT REPAIR FOUND THE UNIT HAD A DAMAGED CASE, BROKEN PE PORT, AND AMP SATURATION ON ANALOG BOARD. THEY REPLACED THE UNIT ANALOG BOARD, CASE, PE PORT, AND BATTERY. THE UNIT WAS RETESTED PER DM-TF-061, ALL TESTS PASSED. NO RELATED CAPAS. THIS COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW. INVESTIGATION RESULT CODE: NEURO SBU/PHYSICAL DAMAGE

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF TO NATUS COMPLAINT # (B)(4). DETAILS FOR SECTION D4. TO BE CONFIRMED. A QUESTIONNAIRE HAS BEEN SENT TO THE CUSTOMER. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    EEG (ELECTROENCEPHALOGRAM) HAD LAPSE(S) IN RECORDING DURING PATIENT TESTING FOR ELECTIVE EPILEPSY MONITORING. PROCEDURE AT THE TIME: EMU MONITORING. PER RETURNED QUESTIONNAIRE FROM THE CUSTOMER THE AFFECTED ITEM WAS IDENTIFIED AS PART 006562 EMU40EX BREAKOUT BOX. THEY NOTED THE FOLLOWING: WE WERE USING THIS PORTABLE EEG MACHINE TO RECORD EEG IN OUR EPILEPSY MONITORING UNIT WHEN SUDDENLY THE MONITOR SHOWED "BREAKOUT BOX DISCONNECTED". AT THE TIME, NOBODY TOUCHED THE HEAD BOX NOR THE MACHINE. A FEW MINUTES AFTER THIS, EEG READER WASN'T ABLE TO REMOTE IN AND THE MACHINE STOPPED RECORDING. THIS HAD LED TO LOSS OF EEG RECORDING. THE PATIENT HAD AN EVENT DURING THIS LOSS OF RECORDING INCIDENT THAT LED TO AN INCOMPLETE PRE-SURGICAL EVALUATION. THE PATIENT NEEDED LONGER HOSPITALIZATION AS A RESULT OF THE LOSS OF RECORDING, THE PRE-SURGICAL EVALUATION BECAME INCOMPLETE AND LIKELY NEED A REPEAT EVALUATION IN THE FUTURE.

    Description of Event or Problem · 0

    EEG (ELECTROENCEPHALOGRAM) HAD LAPSE(S) IN RECORDING DURING PATIENT TESTING FOR ELECTIVE EPILEPSY MONITORING. PROCEDURE AT THE TIME: EMU MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677599 EMU40EX BREAKOUT BOX EMU40EX BREAKOUT BOX GWQ NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. 006562

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male