BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN HEARING

    MDR report key: 20083807 · Received August 28, 2024

    Report

    Report Number
    3005650109-2024-00068
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 27, 2024
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296219360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL INVESTIGATION CONCLUDED: DHR REVIEW HAS BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. TRENDED CASE CONCLUSION: IT WAS FOUND A SWITCH IN MATERIAL WAS NEEDED AS WELL AS USER INSTRUCTION UPDATES IN RELATION TO CHANGING OF THE DOME. THE CLINICAL INVESTIGATION CONCLUDED: IT WAS REPORTED THAT THE HEARING CARE PROFESSIONAL BROKE THE RECEIVER NOZZLE WHILE CHANGING A WAX GUARD FOR THE USER. NO HARM TO THE USER WAS REPORTED. CLINICAL CONCLUSION IS THAT THE DETACHED RECEIVER HAS NOT CAUSED HARM TO THE USER. CLINICAL EVALUATION ACCORDING TO CLIN EVAL PLAN&RPT, HA&TSG AND CLIN EVAL PLAN&RPT, OTHER ACC: THE CLINICAL EVALUATION FOR THE DEVICE FAMILY DOES EVALUATE RECEIVERS COMING LOOSE IN THE EAR CANAL. THIS IS IDENTIFIED IN THE RISK ANALYSIS AND MITIGATED THROUGH DEVICE DESIGN BY ENSURING A SUFFICIENT PULL FORCE (COMPLIANCE WITH IEC 60601-2-66). THE USER GUIDE STATES TO CONTACT THE HCP IF A FOREIGN OBJECT OR WAX IS LOCATED IN THE EAR CANAL TO REDUCE THE POTENTIAL RISK OF HARM AS FAR AS POSSIBLE. 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 CONCLUSIONS HEREIN ARE SUFFICIENT. RISK REGISTER REFERENCE: THE RISKS OF MECHANICAL DAMAGE ARE GENERALLY KNOWN, CONSIDERED IN THE RISK ANALYSIS, MITIGATED AND COMMUNICATED TO THE USER. THESE RISKS ARE DEEMED TO BE OF AN ACCEPTABLE NATURE. MANUFACTURERS INVESTIGATION IS FINAL. THIS IS A COMBINED (INITIAL AND FINAL) REPORT.

    Description of Event or Problem · 0

    ON A UNKNOWN DATE 01-JUL-2024 ESTIMATED RECEIVER NOZZLE BROKE WHILE CHANGING A WAX GUARD IN CLINIC FOR THE MEMBER. THERE WAS NO HARM TO END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158497 GN HEARING HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 21384800 05708296219360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown