BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AURICAL OTOCAM 300 TYPE 1076

    MDR report key: 9309581 · Received November 12, 2019

    Report

    Report Number
    9612197-2019-00020
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    March 23, 2018
    Report Date
    December 11, 2019
    Manufacturer
    NATUS MEDICAL DENMARK APS (GN OTOMETRICS)
    Product Code
    ERA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS & FINDINGS THE DEVICE WAS RETURNED FOR EVALUATION. FAILURE WAS CONFIRMED. THE DEVICE WAS REPLACED WITH A REFURBISHED OTOCAM. FUNCTIONAL AND FINAL TESTING WERE CONDUCTED. NO PATIENT IMPACT WAS REPORTED. THIS ISSUE WILL BE CONTINUED TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    COMPLETE DEVICE WAS RETURNED FOR REPAIR. CABLE ISSUE WAS CONFIRMED. NATUS REPLACED THIS WITH A REFURBISHED OTOCAM, AND COMPLETED A FUNCTION TEST AND FINAL TEST. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: PART A: 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. 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. 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

    DAMAGED CABLE ON THE OTO CAM DEVICE, DISCONNECTS WHEN CABLE IS STRAIGHTENED OUT AND EXPOSED WIRES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103210 AURICAL OTOCAM 300 TYPE 1076 AURICAL OTOCAM 300 TYPE 1076 ERA NATUS MEDICAL DENMARK APS (GN OTOMETRICS) 8-04-13250

    Patients

    Seq Age Sex Outcome Treatment
    1 Other