BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICS CHARTR 200 ENG/VNG

    MDR report key: 8893468 · Received August 14, 2019

    Report

    Report Number
    9612197-2019-00003
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Report Date
    November 6, 2019
    Manufacturer
    NATUS MEDICAL DENMARK (GN OTOMETRICS)
    Product Code
    GWN
    PMA / PMN Number
    K061791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT WAS INSPECTED AND IT WAS FOUND THAT THE MAIN BOARD UNIT IS DEFECTIVE AND THE MAIN BOARD IS REQUIRED TO BE REPLACED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS & FINDINGS THE DEVICE WAS RECEIVED BACK FOR REPAIR. IT WAS CONCLUDED THAT THE MAIN BOARD WAS DEFECTIVE. REMEDIAL ACTION/CORRECTIVE ACTION/PREVENTIVE ACTION / FIELD SAFETY CORRECTIVE ACTION THIS ISSUE WILL BE CONTINUED TO BE MONITORED FOR FUTURE REOCCURENCE.

    Additional Manufacturer Narrative · 1

    COMPLETE UNIT RECEIVED BY SERVICE ENGINEER BASED IN (B)(4), SENDING THE UNIT TO NATUS (B)(4). JUSTIFICATION FOR NOT PROVIDING THE BELOW INFORMATION: JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: 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 - NOT APPLICABLE AS THE DEVICE WAS MANUFACTURED IN JANUARY OF 2014. EXPIRATION DATE - DEVICE HAS NO RESTRICTED SHELF LIFE. 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. IF REMEDIAL ACTION INITIATED , CHECK TYPE - THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED.

    Description of Event or Problem · 1

    THE ICS CHARTR 200 IS NOT TURNING ON, IT EVENTUALLY SWITCHES ON AFTER SEVERAL ATTEMPTS BY THE CUSTOMER HOWEVER A WHITE SMOKE STARTED APPEARING UNDERNEATH THE DEVICE AND IT SWITCHED OFF AGAIN. NO PATIENT INVOLVEMENT AT THE TIME THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689339 ICS CHARTR 200 ENG/VNG 1068, ICS CHARTR 200 ENG/VNG GWN NATUS MEDICAL DENMARK (GN OTOMETRICS) 8-04-11910

    Patients

    Seq Age Sex Outcome Treatment
    1 Other