BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICS IMPULSE, 1085

    MDR report key: 8930492 · Received August 26, 2019

    Report

    Report Number
    9612197-2019-00007
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    July 31, 2019
    Report Date
    September 23, 2019
    Manufacturer
    NATUS MEDICAL DENMARK APS (GN OTOMETRICS)
    Product Code
    GWN
    PMA / PMN Number
    K151504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS REPAIRED AND SENT BACK TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SENT THE DEVICE BACK TO NATUS (B)(4) FOR EVALUATION. TECHNICAL TEAM REVIEWED THE RETURNED DEVICE AND THE FOLLOWING WAS COMPLETED: REPLACEMENT OF THE IMPULSE ON SUSPECTED ERROR = NEW ATO IMPULSE. SAFETY AND FINAL TEST WAS SUCCESSFULLY COMPLETED AND OK. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: PATIENT INFORMATION - NO PATIENT INVOLVEMENT. 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

    CUSTOMER NOTICED INCONSISTENT RESULTS DURING PRE-CLINIC TESTING AND THE DEVICE WAS REMOVED FROM USE. THIS WAS DISCOVERED AT PRE CLINIC TESTING AND NOT USED ON A PATIENT. THIS HAD THE POTENTIAL RISK OF MISDIAGNOSES IF USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723031 ICS IMPULSE, 1085 ICS IMPULSE, 1085 GWN NATUS MEDICAL DENMARK APS (GN OTOMETRICS) 8-04-16217

    Patients

    Seq Age Sex Outcome Treatment
    1 Other