BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEFIT

    MDR report key: 22175436 · Received June 10, 2025

    Report

    Report Number
    9612197-2025-00004
    Event Type
    Injury
    Date Received
    June 10, 2025
    Date of Event
    May 27, 2025
    Report Date
    July 16, 2025
    Manufacturer
    NATUS MEDICAL DENMARK APS
    Product Code
    ETW
    PMA / PMN Number
    K110286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXTENT OF HEARING DAMAGE TO BE ASSESSED. DEVICE REQUESTED FOR RETURN.

    Additional Manufacturer Narrative · 0

    NO LONG TERM IMPACT ON CUSTOMER, TESTED FOR HEARING LOSS AND MONITORED FOR TINNITUS. CUSTOMER CALLED BACK AND WAS ABLE TO TROUBLESHOOT THE UNIT. FOUND THAT PHYSICAL CONNECTIONS WERE OK EXCEPT THE LOUDSPEAKER, IT WAS IN 1 INSTEAD OF 3. HAD HER MOVE THE SPEAKER TO 3 ON THE AURICAL, AND VERIFIED THE OTHER CONNECTIONS WERE SOUND. SHARED SCREEN VIA WEBEX AND WALKED THROUGH THE SOUND SETTINGS. DEFAULT SOUND DEVICE WAS A HEADSET, CHANGED THAT TO REALTEK AUDIO AND DISABLED AUDIO ENHANCEMENTS ON PERTINENT DEVICES (AURICAL AND HIT). WENT INTO OTOSUITE AND IN CONFIGURATION WIZARD ENSURED THAT THE SPEAKER POSITION WAS CENTER. RAN ROOM CALIBRATION AND UNIT PASSED. PROBE TUBE CALIBRATION ALSO PASSED AND WAS FULLY WITHIN THE BLUE CURVES. UNIT APPEARS TO BE WORKING NORMALLY, APPEARS THAT THE PROBLEM WAS THE SOUND SETTINGS WHICH WE CORRECTED. SHE ASKED WHAT COULD HAVE CHANGED THOSE, ADVISED IT COULD HAVE BEEN A WINDOWS UPDATE. SHE WILL LET US KNOW IF THERE ARE FURTHER QUESTIONS ABOUT SETTINGS FOR THIS OR OTHER UNITS, AND WILL FILE A NEW INCIDENT WITH THEIR HELP DESK IF PROBLEMS RETURN. RISK REVIEW (B)(4) REV 10 - 1053 AURICAL FREEFIT - RISK ANALYSIS, HAZARD 10.18. CAUSE - EXCESSIVE ACOUSTIC PRESSURE DUE TO PROLONGED STIMULATION AT HIGH INTENSITY. INADEQUATE FW DESIGN. EFFECT (HARM) -EAR / HEARING INJURY (MINOR) OR ANNOYANCE. RESIDUAL RISK - MODERATE. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED.

    Description of Event or Problem · 0

    AURICAL RANDOMLY PLAYING ROOM CALIBRATION SOUNDS FAR TOO LOUDLY. SEEMS TO HAVE CAUSED HEARING DAMAGE IN AT LEAST ONE PERSON, NOBODY IS WILLING TO USE THE BOOTH IN CASE IT HAPPENS AGAIN. INFORMATION REQUESTED ON EXTENT OF HEARING DAMAGE.

    Description of Event or Problem · 0

    DURING FREEFIT CALIBRATION THERE WAS NO SOUND, THEN BECAME VERY LOUD SUDDENLY PATIENT WAS SEEN BY DR., HAD HEARING TEST. MONITORED TINNITUS AND TEMPORARY HEARING LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265236 FREEFIT FREEFIT ETW NATUS MEDICAL DENMARK APS 8-62-49100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female