BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 16742055 · Received April 14, 2023

    Report

    Report Number
    3005650109-2023-00047
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    March 24, 2023
    Report Date
    April 14, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296147113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. THE CLINICAL INVESTIGATION CONCLUDED:A DAMAGED POWER SUPPLY OR A POWER SUPPLY OF VERY POOR QUALITY COULD LEAD TO BURN INJURIES AND IN RARE CONDITIONS THERE IS A SMALL RISK THAT A WRONG CHARGING OR DISCHARGING OR A BATTERY THERMAL RUNWAY CAN LEAD TO HIGH TEMPERATURES OR FIRE ACCIDENTS. 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. 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

    12-APR-2023. ESTIMATED DATE OF INCIDENT (B)(6) 2023. IT WAS REPORTED THAT -CHARGER OVERHEATED AND THE PLUG AREA MELTED. BASED ON DESCRIPTION IT IS WHERE THE CABLE PLUGS INTO THE CHARGER (BY THE MINI USB ADAPTER CORD) THE END USER NOTICED THE OVERHEATING AND UNPLUGGED THE CHARGER NO HARM DONE TO THE PATIENT OR TO THEIR HOME. ORIGINAL EQUIPMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403951 GN RESOUND HEARING AID, , AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 20472100 05708296147113

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability