BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AURICAL AUD/PMM, 1081

    MDR report key: 8959353 · Received September 4, 2019

    Report

    Report Number
    9612197-2019-00014
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Report Date
    October 3, 2019
    Manufacturer
    NATUS MEDICAL DENMARK (GN OTOMETRICS)
    Product Code
    EWO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO TREND HAS BEEN IDENTIFIED FOR THIS ISSUE AND NATUS WILL CONTINUE TO MONITOR FOR FUTURE OCCURRENCES.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS FITTED TO A VESA ARM BY THE CUSTOMER, CABLE WAS TOO TIGHT AND HAD WORN THE RUBBER COATING. THE POWER SUPPLY WAS REPLACED. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: 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 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 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 IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. IF EXPLANTED DATE (MM/DD/YYYY) - THIS IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. REPROCESSOR NAME AND ADDRESS - THIS 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 IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. ADVERSE EVENT TERMS - THIS 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 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 IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21USC 360I(F).

    Description of Event or Problem · 1

    980356 - AURICAL - BARE EXPOSED WIRES. AURICAL HAS BARE EXPOSED WIRES WHERE THE BEND OF THE HOLDER IS - SWITCHING ITSELF ON AND OFF. PRODUCT DOES NOT CONNECT TO THE PC AT ALL WIRES MAKE 'ELECTRIC' NOISE. THE DEVICE WAS FITTED TO A VESA ARM BY THE CUSTOMER, CABLE WAS TOO TIGHT AND HAD WORN THE RUBBER COATING. NO RISKS WERE TAKEN AND POWER SUPPLY CABLE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753189 AURICAL AUD/PMM, 1081 AURICAL AUD/PMM, 1081 EWO NATUS MEDICAL DENMARK (GN OTOMETRICS) 8-04-14501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other