BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDX 8 CHANNEL AMPLIFIER 0162

    MDR report key: 19193731 · Received April 26, 2024

    Report

    Report Number
    3010611950-2024-00002
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    April 16, 2024
    Report Date
    September 4, 2024
    Manufacturer
    NATUS NEUROLOGY INCORPORATED
    Product Code
    GWJ
    UDI-DI
    00382830037303
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT (B)(4) INSTALLATION DATE: ON (B)(6) 2019 PER DOC-013953 REV 33 EMG/ IOM MIDDLETON PRODUCTS RISK ASSESSMENT SPREADSHEET HAZARD 13.4 NERVE DAMAGE CAUSE: UNKNOWN INTERNAL FAILURE MODES CAUSE OUTPUTS ABOVE SPECIFICATION LEVELS EFFECTS (HARM): NERVE OR TISSUE DAMAGE MAY OCCUR. INHERENT TO USE OF THE DEVICE - THE HAZARDS IDENTIFIED HAVE BEEN REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISK FOR THESE HAZARDS ARE CATEGORIZED AS HAVING AN RBA RATING OF LOW DUE TO THE NATURE OF THE HAZARD. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. ON (B)(6) 2024: THE CUSTOMER ADVISED THAT THEY ARE IN THE PROCESS OF COMPLETING THE QUESTIONNAIRE. IN THE MEANTIME, THEY HAVE ENGAGED THEIR ENGINEER TO OVERSEE THE INVESTIGATION. BEFORE SENDING THE DEVICE BACK TO NATUS, THEY WOULD LIKE TO ORGANIZE A TIME TO INSPECT THE DEVICE INTERNALLY AND TEST THE DEVICE IN CONJUNCTION WITH A NATUS TECHNICIAN. FOLLOWING THE TESTING, THEY CAN THEN AGREE ON A PROCESS FOR ANY FURTHER ANALYSIS OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). CUSTOMER HAS BEEN ASKED TO PROVIDE PICTURES OF THE BURN AS EVIDENCE. CUSTOMER IS ALSO BEEN TOLD TO TAKE THE DEVICE OUT OF SERVICE. TECHNICAL SERVICE VISITED THE SITE AND PERFORMED ELECTRICAL SAFETY TEST TO THE PATIENT ELECTRODES AND THOSE TESTED PASSED. FURTHER INVESTIGATION FOUND THAT THE CHANNEL 2 PLUS HAD A VOLTAGE OF BETWEEN .7 AND 2.3 VOLTS PRESENT THAT WAS NOT PRESENT ON ANY OTHER CHANNEL. THE CUSTOMER WAS USING A CUSTOMER MADE CONNECTION CABLE AND CONNECTED TO SPES MEDICA DISPOSABLE NEEDLE ELECTRODES. THE CUSTOMER DISPOSED OF THE NEEDLE ELECTRODE THAT WAS CONNECTED TO THE PATIENT. THE NEEDLE ELECTRODE WAS NOT SUPPLIED BY NATUS. AN ADVERSE EVENT QUESTIONNAIRE HAS BEING SENT TO THE CUSTOMER. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 REF NATUS COMPLAINT#(B)(4). (B)(6)2024: THE CUSTOMER WAS INFORMED THAT OPENING THE DEVICE OUTSIDE THE NATUS FACILITY DOES NOT ENSURE THE INTEGRITY OF THE INVESTIGATION. ON THE CONTRARY, SUCH ACTION WILL COMPROMISE THE INTEGRITY OF THE DEVICE AND THE INVESTIGATION. THE CUSTOMER WAS ALSO INFORMED THAT THE (B)(4) OPTIONS THEY PRESENTED ON (B)(6) 2024, OMITTED THE ONLY VIABLE OPTION, WHICH IS FOR THE DEVICE TO BE SENT TO A NATUS FACILITY WHERE AN INVESTIGATION WILL BE PERFORMED. THE CUSTOMER IS FREE TO UNDERTAKE ITS OWN INDEPENDENT INVESTIGATION WITHOUT THE PARTICIPATION OF NATUS, BUT NATUS DOES NOT ACCEPT THE RESULTS OF ANY SUCH UNAUTHORIZED INVESTIGATION. THE CUSTOMER RETURNED THE COMPLETED QUESTIONNAIRE ON (B)(6) 2024. THEY NOTED THE FOLLOWING RELEVANT INFORMATION THAT THEY BELIEVE WOULD BE PERTINENT TO THE INCIDENT: THE BIOMEDICAL ENGINEER STOPPED THE TESTING TO ALLOW THE XRAY MACHINE TO COME IN, RECONNECTED TO A DIFFERENT POWER SOURCE WITHOUT DISCONNECTING TO THE PATIENT. REVIEW OF RISK: PER (B)(4) EMG/ IOM MIDDLETON PRODUCTS RISK ASSESSMENT SPREADSHEET HAZARD 10.2 ELECTRODE BURNS CAUSE: EXCESSIVE STIMULATION OR PATIENT SENSITIVITY (BURN OCCURS NOT IN THE PRESENCE OF ESU (ELECTRO SURGICAL UNITS). EXCESSIVE STIMULATION OR PATIENT IS SENSITIVE - IN NON-ESU CONDITION. EFFECTS (HARM): FIRST DEGREE BURNS. THE HAZARDS IDENTIFIED HAVE BEEN REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISK FOR THESE HAZARDS ARE CATEGORIZED AS HAVING AN RBA RATING OF LOW DUE TO THE NATURE OF THE HAZARD. HAZARDS HAVE ASSOCIATED WARNINGS DISCLOSED IN THE IFU. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. NO DEVICE HISTORY RECORD REVIEW NECESSARY AS PRODUCT HAS BEEN IN USE FOR MORE THAN 2 YEARS. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW. NO RELATED CAPAS. NUMEROUS ATTEMPTS WERE MADE TO GET THE PRODUCT BACK FOR EVALUATION. HOWEVER, THE DEVICE HAS NOT BEEN RETURNED. THEREFORE, THE COMPLAINT WILL BE CLOSED. FAILURE CONFIRMED: NO. INVESTIGATION RESULT CODE: NEURO SBU/PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    EDX 8 CHANNEL AMPLIFIER 0162 - PATIENT WAS UNDER GOING A COCHLEAR IMPLANT SURGERY AND AT THE END OF THE SURGERY THE SURGEON REPORTED THERE WAS A BURN AT THE SITE OF THE CHANNEL 2 ELECTRODES.

    Description of Event or Problem · 0

    EDX 8 CHANNEL AMPLIFIER 0162 - PATIENT WAS UNDER GOING A COCHLEAR IMPLANT SURGERY AND AT THE END OF THE SURGERY THE SURGEON REPORTED THERE WAS A BURN AT THE SITE OF THE CHANNEL 2 ELECTRODES.

    Description of Event or Problem · 0

    EDX 8 CHANNEL AMPLIFIER 0162 - PATIENT WAS UNDER GOING A COCHLEAR IMPLANT SURGERY AND AT THE END OF THE SURGERY THE SURGEON REPORTED THERE WAS A BURN AT THE SITE OF THE CHANNEL 2 ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871563 EDX 8 CHANNEL AMPLIFIER 0162 EDX 8 CHANNEL AMPLIFIER 0162 GWJ NATUS NEUROLOGY INCORPORATED 515-016200 00382830037303

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Female Other