BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AURICAL AUD/PMM, 1081

    MDR report key: 8914350 · Received August 21, 2019

    Report

    Report Number
    9612197-2019-00004
    Event Type
    Injury
    Date Received
    August 21, 2019
    Report Date
    October 16, 2019
    Manufacturer
    NATUS MEDICAL DENMARK APS (GN OTOMETRICS)
    Product Code
    EWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO FAULTS WERE FOUND ON THE DEVICE ON THE RETURNED DEVICE INVESTIGATED. THIS ISSUE WILL BE CONTINUED TO BE MONITORED FOR FUTURE OCCURRENCE.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER INFORMTION UPDATED AND CORRECTED, THIS INFORMATION WAS RECEIVED AFTER INITIAL REPORT. PATIENT INFORMATION, AND DATE OF EVENT REQUESTED.

    Additional Manufacturer Narrative · 1

    ISSUE AFFECTING AURICAL AUD/PMM, 1081 SN (B)(4). NATUS HAS A CLIENT WHO HAS REPORTED THAT THE ABOVE AURICAL (SN: (B)(4)) HAS GIVEN THEM SMALL ELECTRIC SHOCKS THROUGH THE INSERT EARPHONES. NATUS REQUESTED THEY SEND THE DEVICE IN FOR REPAIR/ INSPECTION. THE SERVICE ENGINEER RECEIVED THE DEVICE AND TESTED IT AND WAS UNABLE FIND ANY FAULT OR SIGN OF ANY PROBLEM. THE DEVICE PASSES THE HIPOT TEST. BASED ON THE ON THE INVESTIGATION ABOVE, IT IS CONCLUDED THAT THE AURICAL AUD, PSU AND INSERTS ARE WORKING AS INTENDED. THIS IS CONFIRMED BY THE AURICAL AUD FUNCTION TEST AND TESTS PERFORMED IN OTOSUITE. THE PSU MAKES SURE THAT THERE IS GALVANIC ISOLATION BETWEEN THE MAINS AND AURICAL AUD INSERTS TO PROTECT PATIENTS AND OPERATORS. OUR LEAKAGE CURRENT TESTS CONFIRMS THIS WITH BOTH EARTH LEAKAGE CURRENT AND ENCLOSURE LEAKAGE MEASURED WITHIN ACCEPTABLE LIMITS ACCORDING TO 60601-1 REQUIREMENTS. HIPOT TESTS ALSO CONFIRM THAT THERE IS NO BREAKDOWN OF THE INSULATION OF THE AURICAL AUD, PSU, POWER CABLE OR THE INSERTS. FURTHERMORE, THE INSERT HOUSING IS MADE OUT OF PLASTIC AND THE TUBES ARE MADE OF RUBBER, WHICH ARE POOR CONDUCTORS. THIS MAKES IT HIGHLY UNLIKELY TO RECEIVE AN ELECTRICAL SHOCK THROUGH EITHER MEDIUM. THE MOST LIKELY PLACE TO RECEIVE AN ELECTRICAL SHOCK IS ON THE INSERTS CABLES AND THEY WERE FIRMLY INSTALLED AND INTACT WITH NO OPEN WIRES. THE CONCLUSION IS THAT THE SYSTEM IS NOT AT FAULT TO GIVE THE PATIENTS OR OPERATOR ELECTRICAL SHOCK. IT IS MORE LIKELY THAT THE PATIENT OR OPERATOR EXPERIENCED AN UNCOMFORTABLE ELECTROSTATIC DISCHARGE FROM A PATIENT OR OPERATOR WHILE HOLDING THE INSERTS. 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. PMA/510(K) - THIS DEVICE IS EXEMPT . MANUFACTURE DATE - INFORMATION NOT AVAILABLE AT THE TIME OF THE REPORT THIS WILL BE SUBMITTED IN THE FOLLOW UP REPORT.

    Description of Event or Problem · 1

    ISSUE AFFECTING AURICAL AUD/PMM, 1081, SN (B)(4). AURICAL AUD HAS GIVEN SMALL ELECTRIC SHOCK IN THE INSERT PHONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712101 AURICAL AUD/PMM, 1081 AURICAL AUD/PMM, 1081 EWO NATUS MEDICAL DENMARK APS (GN OTOMETRICS) 8-04-14501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other