BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 19236578 · Received May 3, 2024

    Report

    Report Number
    3005650109-2024-00040
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    March 1, 2024
    Report Date
    April 30, 2024
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# SF (B)(4). MANUFACTURER'S INVESTIGATION: TECHNICAL INVESTIGATION CONCLUDED: IT WAS NOT POSSIBLE TO CONDUCT DEVICE HISTORY RECORD REVIEW AS NO SERIAL NUMBER WAS AVAILABLE. CLINICAL CONCLUSION: IT WAS REPORTED THAT THE TOP PART OF THE RECEIVER SEPARATED FROM BOTTOM HOUSING. NOTHING WAS LEFT IN THE EAR. CLINICAL CONCLUSION IS THAT THE DETACHED RECEIVER HAS NOT CAUSED HARM TO THE PATIENT. CLINICAL EVALUATION ACCORDING TO CLINICAL EVALUATION PLAN: 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 ASSESSMENT: BASED ON THE INFORMATION PROVIDED THIS APPEARS TO BE A KNOWN RISK WHICH IS COVERED BY AN EXISTING CAPA. ALL RESULTING ACTIONS ARE CONTAINED WITHIN THE CAPA WHICH INCLUDES ASSESSMENT OF RISKS AND ASSOCIATED UPDATES. TRENDED CASE DEVICE INVESTIGATION FINDINGS: ANALYSIS CONCLUSION: ROOT CAUSE WERE IDENTIFIED AS PER BELOW: 1. INADEQUATE PFMEA ASSESSMENT ON INSUFFICIENT GLUE APPLICATION. 2. NO MECHANISM TO SPECIFY AND CONTROL THE GLUE APPLICATION AMOUNT SINCE THIS PROCESS IS HUMAN DRIVEN WITH INCONSISTENCY 3. THE EXACT BONDING EVALUATION METHOD IS DIVERT. THE BONDING SHALL BE CONDUCTED BETWEEN HOUSING AND RECEIVER CONTACT POINT. NOT ON FRONT HOUSING TIP AND RECEIVER CABLE INSTEAD. DEVICE INVESTIGATION CONCLUDED: THE RECEIVER WAS DISCARDED SO IT WAS NOT RETURNED TO MANUFACTURER AND THEREFORE NO DEVICE INVESTIGATION COULD BE CONDUCTED.

    Description of Event or Problem · 0

    DATE OF INCIDENT: ESTIMATED (B)(6) 2024. ON (B)(6) 2024 IT WAS REPORTED THAT THE RECEIVER TO THE HEARING AID BROKE. NOTHING WAS LEFT IN THE EAR. NO HARM WAS REPORTED. THE SERIAL NUMBER OF THE RECEIVER IS NOT AVAILABLE. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277630 GN RESOUND HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown