BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 16917803 · Received May 12, 2023

    Report

    Report Number
    3005650109-2023-00057
    Event Type
    Malfunction
    Date Received
    May 12, 2023
    Date of Event
    April 11, 2023
    Report Date
    May 10, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296147120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 CONNECTOR IS BROKEN, PROBABLY BECAUSE THE USER HAS (NOT INTENTIONALLY) MISUSED IT, WHILE INSERTING THE CABLE. IF THE CABLE HAS BEEN SLIGHTLY OUT OF SPECIFICATION THAT COULD HAVE HAD A NEGATIVE EFFECT ON THIS. THIS HAS CAUSED A LOW OHMIC CONNECTION IN THE CABLE CONNECTOR. ALMOST A SHORT CIRCUIT THAT WILL EMIT HEAT WHEN THE CABLE IS INSERTED INTO THE WALL CHARGER, CAUSING UP TO THE RATED 5 W OF THE WALL CHARGER TO BE DISSIPATED INSIDE THE CONNECTOR. MICRO USB IS A VERY WELL KNOWN AND USED STANDARD BUT CAN MECHANICALLY BREAK DOWN. CLINICAL EVALUATION OF THE EVENT: IT HAS BEEN REPORTED THAT 'THE CORD MELTED TO CHARGER'. THE PATIENT NOTICED IT AND UNPLUGGED THE DEVICE. ORIGINAL ACCESSORIES HAVE BEEN USED. BOTH HEARING AIDS WERE IN THE CHARGER WHEN THE INCIDENT HAPPENED. NO PERSONAL HARM OR PROPERTY DAMAGE REPORTED. THE CLINICAL INVESTIGATION CONCLUDED: 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

    ESTIMATED DATE OF INCIDENT (B)(6) 2023. IT WAS REPORTED: CHARGER CORD MELTED WHERE IT PLUGS INTO THE CHARGER ITSELF. USER NOTICED IT UNPLUG IT AND BROUGHT IT INTO THE PROVIDER'S OFFICE. ORIGINAL ACCESSORIES HAVE BEEN USED. BOTH HEARING AIDS WERE IN THE CHARGER WHEN THE INCIDENT HAPPENED. NO HARM TO THE PATIENT OR TO THEIR HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1652688 GN RESOUND HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 20623200 05708296147120

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown