BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEADSET HB-7 (12 KHZ) MATCHED TDH39 PHONES (JACK)

    MDR report key: 9121782 · Received September 26, 2019

    Report

    Report Number
    9612197-2019-00018
    Event Type
    Injury
    Date Received
    September 26, 2019
    Date of Event
    August 26, 2019
    Report Date
    October 22, 2019
    Manufacturer
    NATUS MEDICAL DENMARK APS (GN OTOMETRICS)
    Product Code
    EWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PART NUMBER OF SUSPECT PRODUCT UPDATED FROM 8-75-780 TO 8-75-430. MANUFACTUERER'S DEVICE ANALYSIS RESULTS NO DEFECTIVE UNIT WAS RETURNED FOR EVALUATION AS THE CUSTOMER SCRAPPED THE UNIT. WITHOUT THE SUSPECT DEFECTIVE UNIT BEING RETURNED FOR EVALUATION , IT WAS NOT POSSIBLE TO CONFIRM OR DISPUTE THE FAILURE MODE AS REPORTED BY THE ACCOUNT. AS PART OF THE EVALUATION , THE ASSOCIATED DHR WAS REVIEWED AND NO ANOMALIES WERE IDENTIFIED. THE ASSOCIATED RISK DOCUMENTATION WAS REVIEWED. "ACCIDENTAL DAMAGE, MISHANDLING BY USER" WAS IDENTIFIED AS A HAZARD AND THE RESIDUAL RISK ASSOCIATED WITH THIS HAZARD WAS DEEMED LOW AND THE RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. THIS COMPLAINT IS BEING CLOSED OUT ON THE BASIS OF NO PRODUCT BEING RETURNED FOR EVALUATION. REMEDIAL ACTION/CORRECTIVE ACTION/PREVENTIVE ACTION / FIELD SAFETY CORRECTIVE ACTION THIS HAS BEEN DEEMED AN ISOLATED INCIDENT WHICH WILL BE CONTINUED TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    NO FURTHER INVESTIGATION CAN BE COMPLETED ON THE DEFECTIVE PRODUCT AS THE HEADSET HAS BEEN DISCARDED BY THE CUSTOMER. PATIENT INFORMATION - INFORMATION ON THE ETHNICITY OF THE PATIENT IS UNKNOWN. LOT # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE A LOT NUMBER. SERIAL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE A LOT NUMBER. UDI - THIS IS AN ACCESSORY PART AND DOES NOT HAVE A UDI. EXPIRATION DATE - THIS INFORMATION IS UNKNOWN AS NO SERIAL NUMBER OR LOT NUMBER PROVIDED. 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. 510K - THIS PRODUCT WAS EXEMPT FROM 510K. 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 -THIS INFORMATION IS UNKNOWN AS NO SERIAL NUMBER OR LOT NUMBER PROVIDED. 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

    THE HEADSET WAS HAS BROKEN DURING A TEST WITH A PATIENT. IN THE MOMENT THE HEADSET WAS BEING ADJUSTED ON THE PATIENT, THE HEADBAND BROKE AND HIT THE PATIENT IN THE HEAD. THIS RESULTED IN A MILD HEADACHE ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918680 HEADSET HB-7 (12 KHZ) MATCHED TDH39 PHONES (JACK) HEADSET HB-7 (12 KHZ) MATCHED TDH39 PHONES (JACK) EWO NATUS MEDICAL DENMARK APS (GN OTOMETRICS) 8-75-430

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other