BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AURICAL AUD/PMM, 1081

    MDR report key: 8954797 · Received September 3, 2019

    Report

    Report Number
    9612197-2019-00010
    Event Type
    Injury
    Date Received
    September 3, 2019
    Date of Event
    November 9, 2018
    Report Date
    October 2, 2019
    Manufacturer
    NATUS MEDICAL DENMARK (GN OTOMETRICS)
    Product Code
    EWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS CONCLUDED THAT THE AURICAL AUD DEVICE AND CIRCUITS, THE PLASTIC PIECE, THE SPEAKER, THE DAMAGED NB71 CABLE, DEFECT SHIELDING ON USB CABLE WAS NOT AT FAULT TO GIVE THE CUSTOMER AN ELECTRICAL SHOCK BASED ON THE MEASUREMENTS PERFORMED. DESPITE BEING ABLE TO RECREATE THE CRACKLING SOUND WITH THE MEDICAL POWER ADAPTER AND POWER CABLE, BY INSERTING THE POWER CABLE LOOSELY IN THE SOCKET OF THE MEDICAL POWER ADAPTER, THE CURRENT MEASURED AFTER DISCONNECTING WAS VERY LOW AROUND 30-40UA AC. DISCONNECTING AND CONNECTING THE POWER CABLE WITH THE MEDICAL POWER SUPPLY DID NOT CREATE SPARKS. THE POWER CABLE 8-71-80200 WAS TESTED IN A HIGH VOLTAGE VACUUM CHAMBER WITH A DIELECTRIC WITHSTAND TESTER AND THE CABLES DIELECTRIC STRENGTH HOLDS WHILE BEING EXPOSED TO 4000KV. IT IS OUR RECOMMENDATION THAT THE MEDICAL POWER SUPPLY IS SENT TO THE MANUFACTURER FOR FURTHER TESTING AS THE CABLE HAS BEEN CONFIRMED TO BE IN GOOD CONDITION. ROOT CAUSE INVESTIGATION PERFORMED BY SUPPLIER CONFIRMS THAT PARTS ARE PERFORMING AS PER SPECIFICATION. THE MANUFACTURER COULD NOT REPRODUCE THE INCIDENT AFTER INTERNAL TEST. BOTH THE INTERNAL AND MANUFACTURER INVESTIGATION IS SUPPORTING THE ASSUMPTION THAT THE POTENTIAL ROOT CAUSE IS AT THE CUSTOMER SET UP. THIS WAS AN ISOLATED INCIDENT. CAPA(B)(4) - ROOT CAUSE INVESTIGATION PERFORMED BY SUPPLIER CONFIRMS THAT PARTS ARE PERFORMING AS PER SPECIFICATION. THEREFORE NO CORRECTIONS AND CORRECTIVE ACTIONS COULD BE DETERMINED. THIS WILL BE CONTINUED TO BE MONITORED FOR FUTURE OCCURRENCES.

    Additional Manufacturer Narrative · 1

    JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: PART A: PATIENT INFORMATION - THIS EVENT DID NOT EFFECT THE PATIENT AND AFFECTED THE USER. NO FURTHER HOSPITALISATION/TREATMENT. RELEVANT TESTS / LABORATORY DATA - NO RELEVANT TESTS OR LABORATORY DATA. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: NOT APPLICABLE. 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. 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 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. PMA/510(K) - THIS DEVICE IS EXEMPT. 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. MANUFACTURE DATE - INFORMATION NOT AVAILABLE AT THE TIME OF THE REPORT THIS WILL BE SUBMITTED IN THE FOLLOW UP REPORT. (B)(4)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

    AUDIOLOGIST RECEIVED A SHOCK TO THE HAND (TINGLING SENSATION) AND DEVICE STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752011 AURICAL AUD/PMM, 1081 AURICAL AUD/PMM, 1081 EWO NATUS MEDICAL DENMARK (GN OTOMETRICS) 8-04-14500

    Patients

    Seq Age Sex Outcome Treatment
    1 Other