BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AURICAL AUD 1081

    MDR report key: 23541589 · Received November 13, 2025

    Report

    Report Number
    9612197-2025-00009
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    November 10, 2025
    Report Date
    November 13, 2025
    Manufacturer
    NATUS MEDICAL DENMARK
    Product Code
    EWO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT OF COMPLAINT (B)(4). DEVICE REQUESTED FOR RETURN. RISK REVIEW: (B)(4) REV 13 - 1081 AURICAL AUD HAZARD 2.1. CAUSE - OVER VOLTAGE CONDITION DUE TO INPUT VOLTAGE EXCEEDS RANGE (FOR MAIN UNIT) EFFECT - FIRE - SMOKE INHALATION, SECOND DEGREE BURNS, THIRD DEGREE BURNS AND/OR ENVIRONMENTAL DAMAGE RESIDUAL RISK - MODERATE

    Description of Event or Problem · 0

    AURICAL AUD BECAME VERY HOT, ACCORDING TO USER. HOUSING AT POWER SUPPLY CONNECTION SLIGHTLY WARPED AND SCORCHED AS A RESULT. AURICAL AUD IS INSTALLED IN A DRAWER. HOWEVER, THE USER SAYS THAT THE REPLACEMENT DEVICE DOES NOT GET AS HOT THERE EITHER. NO PATIENT OR USER HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882918 AURICAL AUD 1081 AUDIOMETER EWO NATUS MEDICAL DENMARK 8-04-14503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown