BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARTR 200, 1068

    MDR report key: 8921211 · Received August 22, 2019

    Report

    Report Number
    9612197-2019-00006
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Report Date
    September 19, 2019
    Manufacturer
    NATUS MEDICAL DENMARK APS (GN OTOMETRICS)
    Product Code
    GWN
    PMA / PMN Number
    K061791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REQUESTED THE DEVICE TO BE RETURNED TO THEM. DEVICE WAS SENT BACK TO THE CUSTOMER. NO FURTHER INVESTIGATION COMPLETED ON THE DEVICE. THIS ISSUE WILL BE MONITORED FOR FUTURE OCCURRENCES.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT BACK FOR REPAIR, AT THE TIME NATUS WAS UNABLE TO REPAIR WITHIN A NORMAL TURN AROUND TIME DUE TO A SUPPLIER ISSUE. THE CUSTOMER REQUESTED THE DEVICE TO BE RETURNED TO THEM. DEVICE WAS SENT BACK TO THE CUSTOMER. 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 CHARTR 200, 1068; SN: (B)(4). IT DIDN'T WORK AFTER BURNING SMELL, CUSTOMER COULD SEE BURNT BOARD WHEN WE CHECK INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713352 CHARTR 200, 1068 CHARTR 200, 1068 GWN NATUS MEDICAL DENMARK APS (GN OTOMETRICS) 8-04-11910

    Patients

    Seq Age Sex Outcome Treatment
    1 Other