BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-PRO 2, 1072

    MDR report key: 8954958 · Received September 3, 2019

    Report

    Report Number
    9612197-2019-00011
    Event Type
    Injury
    Date Received
    September 3, 2019
    Date of Event
    February 6, 2019
    Report Date
    October 2, 2019
    Manufacturer
    NATUS MEDICAL DENMARK (GN OTOMETRICS)
    Product Code
    ESD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO REMEDIAL ACTION / CORRECTIVE ACTION PERFORMED AS FAULT WAS NOT FOUND OR COULD NOT BE REPRODUCED ON INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE HIPRO2 HAS BEEN INVESTIGATED BY THE R&D TEAM. PLEASE FIND BELOW THE INPUT GIVEN BY THE R&D TEAM: PERFORMED THE HI-POT TEST ACCORDING TO WI 60-54-0171_REV10 ON THE DEVICE, S/N (B)(4), AND IT PASSED. (NO LOG OR TEST REPORT IS BEING GENERATED AT THIS POINT IN THE FINAL TEST). REGARDING THE SAFETY OF THE HI-PRO 2. THE HI-PRO 2 HAS BEEN TESTED BY UL TO MEET IEC (B)(4) REQUIREMENTS, WHICH INCLUDES A HI-POT TEST. THIS UL TEST SUBSTANTIATES THAT THE PRODUCT IS SAFE. THE HI-PRO 2 IS ONLY POWERED BY USB (5VOLT DC) FROM THE COMPUTER CONNECTED TO THE HI-PRO 2, AND CANNOT GENERATE HIGH VOLTAGE ON IT'S OWN. THE CUSTOMER WAS ASKED THE FOLLOWING QUESTIONS AND ANSWERS ARE BELOW EACH: TIME AND DATE WHEN SITUATION OCCURRED: (B)(6) 2019 AT AROUND 1:30PM PLEASE STATE EXACTLY WHICH PART OF THE BODY WAS SHOCKED: LEFT FINGERS AND SHOCK CONTINUED UP THE LEFT ARM PLEASE STATE WHAT PART OF THE DEVICE SHE WAS HOLDING AT TIME OF SHOCK: THE SHOCK HAPPENED WHEN I PICKED UP THE MOTION 1PX SP [SUPER POWERED] HEARING AID CONNECTED TO THE RIGHT PORT OF THE HIPRO 2 [CONNECTED TO A LAPTOP VIA USB PORT, THE LAPTOP WAS ON CHARGER CONNECTED TO THE WALL SOCKET]. OTHER DETAILS: MOTION 1P WAS CONNECTED TO LEFT PORT. OFFICIAL SIVATOS CABLES SUPPLIED BY (B)(4). MEDRX PLUGGED OTHER USB PORT, NO OTHER DEVICE CONNECT TO COMPUTER OR HEARING AIDS. BOTH HEARING AIDS WHERE USING THEIR OWN ONBOARD BATTERY AND NOT ON A CHARGING DEVICE AT THE TIME. PLEASE STATE WHAT SHE WAS ATTEMPTING TO DO WHEN SHOCKED: ABOUT TO PLACE MOTION 1PX SP ON THE CLIENTS EAR (ALREADY CONNECTED TO SOFTWARE). WOULD THE AUDIOLOGIST CLASSIFY THE SHOCK AS MILD (STATIC LIKE) / MEDIUM (PAINFUL) / HIGH (STRONG PAINFUL JOLT): MILD, FELT LIKE CARPET STATIC DISCHARGE. IS THERE ANY BURN OR VISIBLE SIGNS FROM THE SHOCK? (IF SO PLEASE TAKE A PHOTO): NO. DID THE USER (AUDIOLOGIST) SEEK MEDICAL ATTENTION? IF YES, PLEASE CONFIRM WHAT WAS THE MEDICAL ADVICE: NO IS THE USER CONCERNED ABOUT THE SAFETY IMPACT? NO. DOES THE USER/CUSTOMER WANT TO HAVE A FOLLOW UP AFTER THE ISSUE IS CLOSED/PROBLEM FIXED? CLOSED. USER AGREED THAT DC VOLTAGE WASN'T DANGEROUS, AND THE USER AGREED THAT THE SHOCK COULD'VE BEEN DUE TO STATIC DISCHARGE FROM HER SHOES ON THE CARPET. SHE REPORTED THE INCIDENT JUST IN CASE THERE WAS A KNOWN FAULT WITH THE HEARING AIDS CONNECTED TO HIPRO2, GIVEN THE FACT THAT OTHER STATIC SHOCKS HAVE OCCURED IN THE PAST [SHE WAS ENSURING THAT IT WAS POSSIBLY HER SHOES ON THE CARPET AND NOT A KNOWN FAULT WITH THE DEVICES INVOLVED]. ENSURE ALL PARTS INVOLVED IN THE INCIDENT ARE SENT BACK FOR INVESTIGATION (ADAPTERS+ POWER LEAD+ DEVICE). NOT YET. USER WILL SEND BACK VIA SIVATOS NEXT WEEK. FURTHERMORE A PICTURE OF THE WALL SOCKET IS REALLY APPRECIATED. USER AGREED TO EMAIL A PICTURE WHEN SHE IS IN THE CLINIC NEXT WEEK. PATIENT INFORMATION - THIS EVENT DID NOT EFFECT THE PATIENT, THE EVENT AFFECTED THE USER. NO FURTHER HOSPITALISATION/TREATMENT. RELEVANT TESTS / LABORATORY DATA - NO RELEVANT TESTS OR LABORATORY DATA. 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.

    Description of Event or Problem · 1

    SHOCK RECEIVED WHEN PICKING UP THE HEARING INSTRUMENT FROM THE DESK, CONNECTED TO THE HIPRO2. CUSTOMER INFORMED NATUS: "THE SHOCK HAPPENED WHEN I PICKED UP THE MOTION 1PX SP [SUPER POWERED] HEARING AID CONNECTED TO THE RIGHT PORT OF THE HIPRO 2 [CONNECTED TO A LAPTOP VIA USB PORT, THE LAPTOP WAS ON CHARGER CONNECTED TO THE WALL SOCKET]. OTHER DETAILS: MOTION 1P WAS CONNECTED TO LEFT PORT. OFFICIAL SIVATOS CABLES SUPPLIED BY (B)(4). MEDRX PLUGGED OTHER USB PORT, NO OTHER DEVICE CONNECT TO COMPUTER OR HEARING AIDS. BOTH HEARING AIDS WHERE USING THEIR OWN ONBOARD BATTERY AND NOT ON A CHARGING DEVICE AT THE TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752302 HI-PRO 2, 1072 HI-PRO 2, 1072 ESD NATUS MEDICAL DENMARK (GN OTOMETRICS) 8-04-14800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other