BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 18038944 · Received October 31, 2023

    Report

    Report Number
    3005650109-2023-00139
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    September 1, 2023
    Report Date
    November 23, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# (B)(4). INVESTIGATION PENDING TO BE SUBMITTED IN A FOLLOW UP REPORT. RELATED CASES: MDR 3005650109-2023-00138 (B)(4), MDR 3005650109-2023-00140 (B)(4). THIS IS A LATE CASE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF#(B)(4). INVESTIGATION PENDING TO BE SUBMITTED IN A FOLLOW UP REPORT. RELATED CASES: MDR 3005650109-2023-00138 SF(B)(4). MDR 3005650109-2023-00140 SF(B)(4). THIS IS A LATE CASE. MANUFACTURER'S INVESTIGATION: TECHNICAL INVESTIGATION CONCLUDED: DEVICE HISTORY RECORD REVIEW HAS BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. THE CLINICAL INVESTIGATION CONCLUDED: CLINICAL CONCLUSION IS THAT THE DETACHED RECEIVER HAS NOT CAUSED HARM TO THE PATIENT AND NO MEDICAL TREATMENT/MEDICAL INTERVENTION NECESSARY. 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 REGISTER 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. THE RISK IS IDENTIFIED AND EVALUATED IN THE RISK ANALYSIS. THE RISK IS DEEMED TO BE ACCEPTABLE. TRENDED CASE DEVICE INVESTIGATION CONCLUDED: 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. CAPA INITIATED. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS FINAL REPORT.

    Description of Event or Problem · 0

    ESTIMATED DATE OF INCIDENT (B)(6) 2023. ON (B)(6) 2023 IT WAS REPORTED: HEARING CARE PROFESSIONAL (HCP) CONTACTED MANUFACTURER BY EMAIL AN EXPLAINED THAT SHE HAD 4 DIFFERENT PATIENTS COME IN WITH BROKEN RECEIVERS. HCP DID NOT REPORT ANY INJURY FOR THESE BROKEN RECEIVER CASES. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    ESTIMATED DATE OF INCIDENT (B)(6) 2023 ON (B)(6) 2023 IT WAS REPORTED: HEARING CARE PROFESSIONAL (HCP) CONTACTED MANUFACTURER BY EMAIL AND EXPLAINED THAT SHE HAD 4 DIFFERENT PATIENTS COME IN WITH BROKEN RECEIVERS. HCP DID NOT REPORT ANY INJURY FOR THESE BROKEN RECEIVER CASES. NO FURTHER INFORMATION AVAILABLE. 21NOV2023 NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882140 GN RESOUND HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 2265118991

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown