BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITERA II, 1004

    MDR report key: 8915353 · Received August 21, 2019

    Report

    Report Number
    9612197-2019-00005
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Report Date
    September 18, 2019
    Manufacturer
    NATUS MEDICAL DENMARK APS (GN OTOMETRICS)
    Product Code
    EWO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CAPA(B)(4) WAS OPENED TO INVESTIGATE THIS ISSUE FURTHER: THE ROOT CAUSE FOUND IS A COMBINATION OF THREE FACTORS: 1) LOW RESISTANCE VALUE (5 OHM) ON J3 POWER RESISTOR (CAUSING HIGH TEMPERATURE) 2) TAPE ON THE TOP AND BOTTOM SIDE OF THE RESISTOR, PARTLY ISOLATING IT FROM THE HEATSINK / PSU FRAME 3) SCREW NOT TIGHT - CAUSING POOR CONTACT BETWEEN POWER RESISTOR AND THE HEATSINK / PSU FRAME THE COMBINATION OF HIGH TEMPERATURE RESISTOR AND POOR HEAT DISSIPATION DUE TO REDUCED CONTACT TO HEATSINK CAUSES THE TAPE/LABEL ON THE RESISTOR TO TURN BROWN AND SMELL. ACTION PLAN: ACTION-A: VERIFY COMPLAINT HISTORY - FOR NO OR VERY LOW REOCCURRENCE OF SAME FAILURE CONDITION ACTION-B: QUARANTINE AND REWORK ALL XETA ATO'S IN WIP AND INVENTORY, WHICH WERE PRODUCED PRIOR TO ECO#26967 ACTION-C: IMMIDIATELY INFORM SUPPLIER NOT TO MARK THE J3 RESISTOR - RESOLVE MISUNDERSTANDING OF DRAWING. ACTION-D: UPDATE DRAWINGS (8-35-2210 OG 8-35-2260) TO ENSURE NO MARKING OF J3 ACTION-E: UPDATE ATO ASSEMBLY WORK INSTRUCTION 60-21-0161 (ITERA2) AND 60-21-0371 (XETA) TO SPECIFY SCREW TORQUE ACTION-F: RELEASE SERVICE BULLETIN ACTIONS COMPLETED ON THE 06TH OF(B)(6)2019.

    Additional Manufacturer Narrative · 1

    CUSTOMER STATES: "THE PROBLEM THAT BONE OUTPUT VALUE IS LOW AND THE OFFSET VALUE IS HIGH, THE ABOVE SYMPTOM OCCURS EVEN WHEN A NEW BONE CONDUCTOR IS INSTALLED. AND THERE IS BURNING SMELL FROM BEHIND THE DEVICE." THE PRODUCT WAS RETURNED FOR INSPECTION AND REPAIR: REPAIR TASK - BURNING SMELL CAUSED BY 5 OHM RESISTOR, CHANGED TO 10 OHM. TESTED FUNCTION TO SPECIFICATION AS PER DOC NO. (B)(4) WITH NO FAULTS DETECTED. REPAIRED 1004 MADSEN ITERA II, INCL. OTOSUITE SW AND STANDARD ACCESSORIES, EXCL. HEADSET SHIPPED BACK TO CUSTOMER ON 12 JUN '18. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: PART A: PATIENT INFORMATION - NO PATIENT INVOLVEMENT. DATE OF EVENT - DATE OF EVENT IS UNKNOWN AND WILL BE REQUESTED FROM THE CUSTOMER. RELEVANT TESTS / LABORATORY DATA - THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY REPORTED. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY REPORTED. LOT # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE A LOT NUMBER. UDI - INFORMATION NOT AVAILABLE AT THE TIME OF THE REPORT THIS WILL BE SUBMITTED IN THE FOLLOW UP REPORT. EXPIRATION DATE - INFORMATION NOT AVAILABLE AT THE TIME OF THE REPORT THIS WILL BE SUBMITTED IN THE FOLLOW UP REPORT. IF IMPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. IF EXPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. REPROCESSOR NAME AND ADDRESS - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDING TREATMENT OF EVENT) - THIS SECTION IS NOT APPLICABLE TO THIS TYPE OF DEVICE. FOR USE BY USER FACILITY / IMPORTER - NOT APPLICABLE AS WE ARE NOT A FACILITY OR IMPORTER OF DEVICE. IF ND, GIVE PROTOCOL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. ADVERSE EVENT TERMS - THIS SECTION IS NOT APPLICABLE TO MEDICAL DEVICES. MANUFACTURE DATE - INFORMATION NOT AVAILABLE AT THE TIME OF THE REPORT THIS WILL BE SUBMITTED IN THE FOLLOW UP REPORT. IF REMEDIAL ACTION INITIATED , CHECK TYPE - THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. IF ACTION REPORTED TO FDA UNDER 21 USC 360I (F), LIST CORRECTION / REMOVAL REPORTING NUMBER - THIS SECTION IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21USC 360I(F).

    Description of Event or Problem · 1

    ISSUE AFFECTING ITERA, 1004 SN (B)(4). AC, BONE CONDUCTOR OUTPUT VALUE ARE LOW AND BURNING SMELL FROM BOARD AND POWER SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708080 ITERA II, 1004 ITERA II, 1004 EWO NATUS MEDICAL DENMARK APS (GN OTOMETRICS) 8-04-02200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other