BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN HEARING

    MDR report key: 20319117 · Received September 27, 2024

    Report

    Report Number
    3005650109-2024-00076
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 26, 2024
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296219438
    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). TECHNICAL INVESTIGATION CONCLUDED: DHR REVIEW HAS BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. TRENDED CASE CONCLUSION: ADHESIVE FAILURE MODE IS OBSERVED ON FAILED DEVICES. ADHESIVE TO ADHERENT INTERFACES DETACHED FROM EACH OTHER. ADHESIVE FAILURE MODES OCCUR DUE TO SEVERAL FACTORS SUCH AS INAPPROPRIATE ADHESIVE SELECTION, PURE SURFACE PREPARATION, AND EXPOSURE TO ENVIRONMENTAL FACTORS. ASSEMBLY LINES DO NOT OVERLAP TOTALLY BUT LEAVE OPEN GAPS, CREATING POCKETS FOR INGRESS AND RETENTION OF ADHESION DEGRADING MEDIA. USED ADHESIVE TECHNICAL SHEET SUGGESTS AVOIDING ADHESIVE USAGE IN CHLORINATED ENVIRONMENTS - WE HAVE BODY CONTACTS. THE CLINICAL INVESTIGATION CONCLUDED: IT WAS REPORTED THAT A SF3 RECEIVER CAME APART IN HANDS WHILE HEARING CARE PROVIDER (HCP) WAS CLEANING THE HEARING AIDS. CLINICAL CONCLUSION IS THAT THE DETACHED RECEIVER HAS NOT CAUSED HARM TO THE USER OR HCP. 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: RISK RELATED TO MECHANICAL DAMAGE ARE GENERALLY KNOWN MITIGATED AND COMMUNICATED TO THE USER. FOR THIS RISK, REFER TO CAPA. ALL RESULTING ACTIONS ARE CONTAINED WITHIN THE CAPA WHICH INCLUDES ASSESSMENT OF RISKS AND ASSOCIATED UPDATES. MANUFACTURERS INVESTIGATION IS FINAL. THIS IS A COMBINED (INITIAL AND FINAL) REPORT.

    Description of Event or Problem · 0

    PATIENT CAME IN THE OFFICE OF THE HEARING CARE PROFESSIONAL FOR HIS 4 MONTH SERVICE APPOINTMENT ON AUGUST 29TH. WHILE CLEANING THE HEARING AID AND REMOVING THE LEFT DOME, THE TOP PART OF THE RECEIVER FELL OFF. IT NEVER CAME OFF IN THE PATIENT'S EAR. NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739390 GN HEARING HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 21385500 05708296219438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male