BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELTONE

    MDR report key: 16937914 · Received May 16, 2023

    Report

    Report Number
    3005650109-2023-00060
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Report Date
    May 16, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296214457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# SF03064378. 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 "CHARGER MELTED'. ORIGINAL ACCESSORIES HAVE BEEN USED. NO PERSONAL HARM OR PROPERTY DAMAGE REPORTED. 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. NO FURTHER FOLLOW UP IS EXPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED- ACHIEVE CHARGER MELTED CHARGER WAS BROUGHT ON (B)(6) 2023. NO HARM DONE TO THE PATIENT OR PROPERTY. ORIGINAL EQUIPMENT WAS USED. RECOMMENDATION FROM THE HCP: USE CHARGER AS PER THE INSTRUCTIONS. DO NOT USE ANY OTHER USB CABLES OR PLUGS OTHER THAN WHAT CAME WITH THE CHARGER (MORE OF A REMINDER SINCE THE INCIDENT DID NOT INVOLVE ANY AFTER MARKET PARTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2196410 BELTONE HEARING AID, , AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 21790400 05708296214457

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown