BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARTR EP 200

    MDR report key: 8850521 · Received August 1, 2019

    Report

    Report Number
    9612197-2019-00001
    Event Type
    Malfunction
    Date Received
    August 1, 2019
    Date of Event
    August 27, 2018
    Report Date
    November 18, 2019
    Manufacturer
    GN OTOMETRICS (NATUS DENMARK)
    Product Code
    GWJ
    PMA / PMN Number
    K143670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DEVICE REQUESTED TO BE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    THE DHR WAS REVIEWED: CALIBRATION AND FINAL TEST DOCUMENT, 60-54-0091 PASSED ALL TESTS. ELECTRIC SAFETY TEST DOCUNMENT 60-54-0084 ALSO PASSED. HIGH VOLTAGE TEST DOCUMENT 60-54-0117 ALSO PASSED. CUSTOMER HAS CONFIRMED THEY CAN SEND BACK THE DEVICE TO NATUS FOR INVESTIGATION. NATUS HAS SENT THE CUSTOMER A BOX FOR RETURNING THE PRODUCT AND NATUS ARE WAITING TO RECEIVE THIS.

    Additional Manufacturer Narrative · 1

    UPDATE 24TH OCTOBER 2019 - TECHNICAL SERVICES HAVE CONFIRMED THAT THE SUSPECT UNIT HAS BEEN RETURNED AND IS CURRENTLY IN DEPOT REPAIR.

    Additional Manufacturer Narrative · 1

    NATUS (B)(4) MEDICAL IDENTIFIED THAT CHARTR EP 200 UNITS MANUFACTURED ARE NOT COMPLIANT WITH (B)(4) 2ND AND 3RD EDITION. AN FCA ASSESSMENT HAS BEEN COMPLETED (B)(4), AND THE DECISION HAS BEEN MADE THAT THIS ISSUE IS A REPORTABLE RECALL. A FIELD CORRECTIVE ACTION FOR CHARTR EP 200 AND ITS ASSOCIATED ELECTRODES IS ONGOING AND THIS FCA IS BEING DOCUMENTED THROUGH (B)(4). THIS CUSTOMER WAS NOTIFIED OF THE REPORTABLE FCA AND RESPONDED TO THIS NOTING THAT 4-9 MONTHS AGO THEY HAD ONE PATIENT WHO STATED DURING THE EXAMINATION AND AFTERWARDS THAT SHE HAD FELT DISTINCT AND VERY UNPLEASANT ELECTRIC SHOCKS IN THE HEAD AND NECK. THIS ISSUE WAS ONLY REPORTED TO NATUS ON THE 17TH JULY 2019. (B)(4) POST MARKET RISK ASSESSMENT / HHE WAS REVIEWED. THREE SITUATIONS WERE IDENTIFIED WITH A POTENTIAL HAZARD OF ELECTRICAL SHOCK TO THE PATIENT (ISSUE A, ISSUE D AND ISSUE E). THE OVERALL RISK ESTIMATION WAS 11 (MEDIUM). THE RISK IS AN UNACCEPTABLE RISK SINCE THE CONDITIONS FOR IEC COMPLIANCE FOR CLAUSE 8.5.2.3 ARE NOT MET. DEVICE WILL BE REQUESTED TO BE RETURNED. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: PATIENT INFORMATION - WHILE THERE WAS PATIENT INVOLVEMENT, IT WAS NOTED THAT THE CUSTOMER DID NOT RECEIVE ANY INJURY AFTER RECEIVING THE ELECTRICAL IMPULSES. PART A INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. DATE OF EVENT - THE CUSTOMER NOTED THIS EVENT OCCURRED 4-9 MONTHS AGO BUT DID NOT PROVIDE AN EXACT DATE ON INITIAL REPORTING. RELEVANT TESTS / LABORATORY DATA - THIS IS NOT APPLICABLE AS NO PATIENT INJURY REPORTED. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: THIS IS NOT APPLICABLE AS NO PATIENT INJURY REPORTED. LOT # - THIS 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 IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. IF EXPLANTED DATE (MM/DD/YYYY) - THIS IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. REPROCESSOR NAME AND ADDRESS - THIS 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 IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. ADVERSE EVENT TERMS - THIS 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 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

    DURING AND AFTER EXAMINATION USING THE CHARTR EP 200 DEVICE, PATIENT FELT DISTINCT AND VERY UNPLEASANT ELECTRIC SHOCKS IN THE HEAD AND NECK. "REGARDING THE RECALL OF OUR DEVICE: ICS CHARTR EP 200 SERIAL NO.: (B)(4), WE WOULD LIKE TO REPORT THE FOLLOWING INCIDENT. FROM MEMORY, ABOUT 4-9 MONTHS AGO, ONE PATIENT STATED DURING THE EXAMINATION AND AFTERWARDS THAT SHE HAD FELT DISTINCT AND VERY UNPLEASANT ELECTRIC SHOCKS IN THE HEAD AND NECK, WHICH WAS REGISTERED BY US, BUT WAS INCOMPREHENSIBLE AND THEREFORE WAS NOT PURSUED." NO INJURY OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646294 CHARTR EP 200 CHARTR EP 200 GWJ GN OTOMETRICS (NATUS DENMARK) 8-04-12704

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other