BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN HEARING

    MDR report key: 17001397 · Received May 25, 2023

    Report

    Report Number
    3005650109-2023-00067
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Date of Event
    April 1, 2023
    Report Date
    June 22, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296255153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# (B)(4) ON INVESTIGATION OF THE PHOTO OF THE CHARGER, THE PORT LOOKS MELTED. THE TREND ANALYSIS SHOWS THE USB-C CONNECTOR BREAKS DOWN MECHANICALLY. IT IS A KNOWN PROBLEM WITH USB CONNECTORS, THAT IN RARE CASES WEAR OR DIRT/MOIST CAN CREATE A LOW OHMIC PATH FROM VBUS TO GND, THAT POTENTIAL CAN CAUSE A HEATING INSIDE OF THE CONNECTOR INVESTIGATION IS STILL ONGOING, A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION. 22JUN2023 FOLLOW UP REPORTED: B3 - ADDED DATE 04/01/2023 B4 - UPDATED DATE TO 06/22/2023 G6 - CHANGED TO "FOLLOW UP" AND ADDED FU NUMBER "1" H2 - TICKED "ADDITIONAL INFORMATION" H3 - DEVICE EVALUATED BY MANUFACTURER - CHANGED TO "YES" H4 - DEVICE MANUFACTURE DATE CHANGED FROM 11/03/2022 TO 01/06/2023 H6 - TYPE OF INVESTIGATION ADDED CODE "10 - TESTING OF ACTUAL/SUSPECTED DEVICE" TECHNICAL INVESTIGATION CONCLUDED: A DEVICE HISTORY RECORD REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. TRENDED CASE CONCLUDED: THE USB-C CONNECTOR HAS BROKEN DOWN MECHANICAL. IT IS A KNOWN PROBLEM WITH USB CONNECTORS, THAT IN RARE CASES WEAR OR DIRT/MOIST CAN CREATE A LOW OHMIC PATH FROM VBUS TO GND, THAT POTENTIAL CAN CAUSE A HEATING INSIDE OF THE CONNECTOR. DEVICE INVESTIGATION CONFIRM TRENDED CASE CONCLUSION. CLINICAL ASSESSMENT CONCLUSION CLINICAL EVALUATION: IT IS REPORTED THAT THE USER EXPERIENCED A BURNING SMELL FROM THE CHARGER, AND THAT THE HEARING AIDS ARE HOT AND NO LONGER TURN ON. USER DOES NOT WEAR HEARING AIDS EVERY DAY, AND LEAVES THEM IN THE CHARGER, PLUGGED INTO POWER STRIP FOR 3-4 DAYS. THERE WAS NO REPORT OF HARM TO THE USER, AND NO REPORTED PROPERTY DAMAGE. NO MENTION OF WHETHER THE ACCESSORIES USED WERE ORIGINAL. THE CHARGERS HAVE BEEN TESTED ACCORDING TO APPLICABLE SAFETY STANDARDS. THESE RISKS ARE REDUCED AS FAR AS POSSIBLE AND THE PROBABILITY OF OCCURRENCE OF THESE EVENTS IS CONSIDERED VERY LOW. IN CASE OF MOISTURE, SWEAT OR DIRT IN THE CONNECTOR, THERE CAN BE HIGH TEMPERATURES INSIDE THE CONNECTOR DUE TO POWER DISSIPATION WHEN CONNECTED TO THE CHARGER PLUG. THERE CAN BE MELTING OF THE PLASTIC AROUND THE CONNECTOR AND IS VISIBLE TO THE NAKED EYE. IT IS HIGHLY UNLIKELY THAT THE USER WOULD TOUCH IN CASE THERE APPEARS TO BE MELTING OR HIGH TEMPERATURES. IN THE UNLIKELY EVENT OF THE USER TOUCHING THIS OVERHEATED DEVICE, IT CAN LEAD TO SUPERFICIAL OR MINOR INJURY THAT WOULD IN MOST CASES REQUIRE NO MEDICAL INTERVENTION. THERE ARE NO NEW CLINICAL ASPECTS (E.G., UNFORESEEN USE OR CLINICAL CONDITIONS) DISCOVERED FROM THIS EVENT. THEREFORE, IT IS CONCLUDED THAT THE CURRENT CLINICAL EVALUATION AND RISK/BENEFIT CONCLUSION HEREIN ARE SUFFICIENT. RISK REGISTER CONCLUSION REFERENCE: THE RESIDUAL RISK AFTER THE RISK CONTROL MEASURE(S) IS ACCEPTABLE. NO NEW HAZARDOUS SITUATIONS REVEALED AND NO NEED TO UPDATE THE RISK REGISTER. THIS IS A FINAL REPORT. NO FURTHER FOLLOW UP IS EXPECTED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# (B)(4). ON INVESTIAGTION OF THE PHOTO OF THE CHARGER, THE PORT LOOKS MELTED. THE TREND ANALYSIS SHOWS THE THE USB-C CONNECTOR BREAKS DOWN MECHANICALLY. IT IS A KNOWN PROBLEM WITH USB CONNECTORS, THAT IN RARE CASES WEAR OR DIRT/MOIST CAN CREATE A LOW OHMIC PATH FROM VBUS TO GND, THAT POTENTIAL CAN CAUSE A HEATING INSIDE OF THE CONNECTOR INVESTIGATION IS STILL ONGOING, A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 0

    IT WAS REPORTED: USER WAS "TRYING TO GET USED TO THE HEARING AIDS" SO DOESN'T WEAR EVERY DAY - IN FACT LEAVES THEM IN CHARGER, PLUGGED INTO A POWER STRIP FOR 3-4 DAYS. SHE NOW REPORTS A "BURNING SMELL AND THE AIDS ARE HOT" AND NO LONGER TURN ON. NO FURTHER INFORMATION REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED: USER WAS "TRYING TO GET USED TO THE HEARING AIDS" SO DOESN'T WEAR EVERY DAY - IN FACT LEAVES THEM IN CHARGER, PLUGGED INTO A POWER STRIP FOR 3-4 DAYS. SHE NOW REPORTS A "BURNING SMELL AND THE AIDS ARE HOT" AND NO LONGER TURN ON. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562778 GN HEARING HEARING AID, , AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 22421100 05708296255153

    Patients

    Seq Age Sex Outcome Treatment
    1 Female