BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 17265010 · Received July 6, 2023

    Report

    Report Number
    3005650109-2023-00099
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 1, 2023
    Report Date
    August 4, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296217069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF#(B)(4). THIS IS AN INITIAL REPORT. INVESTIGATION IS STILL IN PROGRESS; A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# SF (B)(4). THIS IS AN INITIAL REPORT. INVESTIGATION IS STILL IN PROGRESS; A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION. (B)(6) 2023: TECHNICAL INVESTIGATION CONCLUDED: A DEVICE HISTORY RECORD REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. NO DEVICE HAS BEEN RECEIVED SO NO TESTING OF ACTUAL DEVICE IS POSSIBLE. CLINICAL EVALUATION: IT WAS REPORTED THAT THE CHARGER PORT MELTED AND ALLEGEDLY CAUGHT ON FIRE. THERE WAS NO HARM TO THE USER, AND THERE IS NO REPORTED PROPERTY DAMAGE. IT IS UNKNOWN IF ORIGINAL ACCESSORIES WERE USED. 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. RISK REGISTER CONCLUSION: REFER TO CAPA0647. ALL RESULTING ACTIONS ARE CONTAINED WITHIN THE CAPA WHICH INCLUDES ASSESSMENT OF RISKS AND ASSOCIATED UPDATES. DEVICE INVESTIGATION ON ACTUAL DEVICE WAS NOT POSSIBLE, AS DEVICE WAS NOT RECEIVED. THE CHARGER ALLEGEDLY CAUGHT ON FIRE, HOWEVER, IT SHOULD BE NOTED THAT NONE OF THE MATERIALS IN THE CHARGER IS CLASSIFIED AS FLAMMABLE. 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. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A FINAL REPORT. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    ESTIMATED DATE OF INCIDENT (B)(6) 2023 IT WAS REPORTED THAT THE CHARGER PORT CAUGHT ON FIRE AND MELTED. NO HARM TO THE USER OR PROPERTY HAS BEEN REPORTED. FURTHER FOLLOW UP IS EXPECTED.

    Description of Event or Problem · 0

    ESTIMATED DATE OF INCIDENT (B)(6) 2023. IT WAS REPORTED THAT THE CHARGER PORT CAUGHT ON FIRE AND MELTED. NO HARM TO THE USER OR PROPERTY HAS BEEN REPORTED. FURTHER FOLLOW UP IS EXPECTED . (B)(6) 2023. NO FURTHER FOLLOW UP RECEIVED DESPITE ATTEMPTS.NO DEVICE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460984 GN RESOUND HEARING AID, , AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 21810900 05708296217069

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown