BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 17162731 · Received June 20, 2023

    Report

    Report Number
    3005650109-2023-00078
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    May 1, 2023
    Report Date
    June 20, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296251261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# (B)(4). 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. THE CLINICAL INVESTIGATION CONCLUDED: IT HAS BEEN REPORTED THAT THE CUSTOM CHARGER OVERHEATED, RESULTING IN MELTING AND BLACK IN SOME AREAS. NO PROPERTY DAMAGE REPORTED. THERE WAS NO HARM TO THE USER, AND THEREFORE NO MEDICAL ATTENTION. IT IS UNCERTAIN IF THE CABLE USED WAS ORIGINAL. REPLACEMENT OF CHARGER AND INSERTS HAS BEEN ORDERED. 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. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A COMBINED (INITIAL AND FINAL) REPORT.

    Description of Event or Problem · 0

    22MAY2023 IT WAS REPORTED THAT CHARGER OVERHEATED "MELTED AND BLACK IN SOME AREAS". CLINICIAN WAS UNABLE TO CONFIRM IF PROPER CHARGING CABLE WAS BEING USED. NO INJURIES TO PATIENT OR PROPERTY. THIS IS A COMBINED REPORT. NO FURTHER FOLLOW UP IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015071 GN RESOUND HEARING AID, , AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 22345400 05708296251261

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown