BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 16137141 · Received January 11, 2023

    Report

    Report Number
    3005650109-2023-00003
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 1, 2022
    Report Date
    January 9, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296147113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF#: (B)(4). MANUFACTURER'S INVESTIGATION: TECHNICAL INVESTIGATION CONCLUDED: DEVICE HISTORY REGISTER REVIEW HAS BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. TRENDED CASE DEVICE INVESTIGATION 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: BASED ON THE RESULT FROM R&D DEVICE INVESTIGATION FROM TRENDED CASE, CLINICAL CONCLUSION ON THIS EVENT IS THAT THERE IS A POTENTIAL RISK OF HEAT DISSIPATION BASED ON THE FINDINGS. THE CASE ALSO STATES THAT IT IS NOT KNOWN WHETHER THE CORD USED WAS THE ONE ISSUED WITH THE CHARGER OR A DIFFERENT ONE. IT IS RECOMMENDED TO USE THE ONE ISSUED WITH THE CHARGER. CLINICAL EVALUATION ACCORDING TO CLINICAL EVALUATION DOCUMENTATION: 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 SAFETY TESTED ACCORDING TO APPLICABLE 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 ASSESSMENT: 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 FINAL REPORT.

    Description of Event or Problem · 0

    ON 12-DEC-2022 IT WAS REPORTED THAT THE CHARGER OVERHEATED AND STARTED MELTING AROUND WHERE THE PLUG GOES IN. THE PATIENT WAS NOT HARMED. THE REPLACEMENT CHARGER HAS BEEN SENT TO THE PATIENT. FOLLOW UP INFORMATION STATES THAT THE PATIENT HAD NOTICED THAT THE CHARGER WAS HOT TO TOUCH, SO HE CALLED CUSTOMER CARE. THE PATIENT UNPLUGGED THE CHARGER AND BOTH CUSTOMER CARE AND THE PATIENT CALLED THE HEARING CARE PROVIDER. AT THE TIME OF THE EVENT THE CHARGER WAS ON PATIENT'S NIGHTSTAND. IT IS NOT COFIRMED WHETHER ORIGINAL CORD AND AC ADAPTOR WERE USED. THE CHARGER WAS PURCHASED ON 23-OCT-2019. NO FURTHER INFORMATION EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193392 GN RESOUND HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 20472100 05708296147113

    Patients

    Seq Age Sex Outcome Treatment
    1 Male