BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 19826618 · Received July 25, 2024

    Report

    Report Number
    3005650109-2024-00060
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 3, 2024
    Report Date
    August 23, 2024
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296219339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# (B)(4). MANUFACTURER'S INVESTIGATION IS ONGOING. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS AN INITIAL REPORT. 23-AUG-2024: DEVICE HISTORY RECORD REVIEW: A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. DEVICE INSPECTION: VERIFIED ON THE PICTURE, THE BOTTOM HOUSING WAS DETACHED FROM THE RECEIVER. CLINICAL ASSESSMENT: CLINICAL EVALUATION OF THE EVENT: IT WAS REPORTED THAT ON 03JUN2024 THE RECEIVER WAS BROKEN AND THE RECEIVER IS DETACHED FROM THE PIECE OF PLASTIC LOCATED IN THE CONTACT BETWEEN THE RECEIVER AND THE CABLES. AND THE HEARING CARE PROFESSIONAL (HCP) THINKS THAT IT IS LIKELY THAT IT OCCURRED WHEN THE HEARING INSTRUMENT WENT TO BE WORN/UNWORN DUE TO THE WEAR. USER IS A FIRST TIME USER AND HAS NOT EXPERIENCED THIS ISSUE BEFORE. THE RECEIVER DID NOT REQUIRE REMOVAL AND NO HARM TO THE USER WAS REPORTED. 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 (B)(4)). 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 : RISK REG 0457500 TTM03. RISK ID ACC-TM-D-US2-17. RISK IS KNOWN, AND RISK CONTROLS ARE IN PLACE. COVERED BY CAPA0641. ALL RESULTING ACTIONS ARE CONTAINED WITHIN THE CAPA WHICH INCLUDES ASSESSMENT OF RISKS AND ASSOCIATED UPDATES. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# (B)(4). MANUFACTURER'S INVESTIGATION IS ONGOING. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION THIS IS AN INITIAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON 03JUN2024 THE RECEIVER OF THE HEARING AID WAS BROKEN AND WHEN IT WAS REPLACED THE HEARING CARE PROFESSIONAL CHECKED THAT THE HEARING AID DIDN'T CHARGE (AND USER SAID IT DIDN'T WORK CORRECTLY). AFTER BEING ASKED ABOUT HOW THE RECEIVER WAS BROKEN, THE HEARING CARE PROFESSIONAL THINKS THAT IS LIKELY THAT IT OCCURRED WHEN THE HEARING INSTRUMENT WENT TO BE WORN/UNWORN DUE TO THE WEAR. THE OBJECT DID NOT REQUIRE REMOVAL AND NO HARM TO THE USER WAS REPORTED. NO FURTHER FOLLOW UP IS EXPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024 THE RECEIVER OF THE HEARING AID WAS BROKEN AND WHEN IT WAS REPLACED THE HEARING CARE PROFESSIONAL CHECKED THAT THE HEARING AID DIDN'T CHARGE (AND USER SAID IT DIDN'T WORK CORRECTLY). AFTER BEING ASKED ABOUT HOW THE RECEIVER WAS BROKEN, THE HEARING CARE PROFESSIONAL THINKS THAT IS LIKELY THAT IT OCCURRED WHEN THE HEARING INSTRUMENT WENT TO BE WORN/UNWORN DUE TO THE WEAR. THE OBJECT DID NOT REQUIRE REMOVAL AND NO HARM TO THE USER WAS REPORTED. NO FURTHER FOLLOW UP IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371183 GN RESOUND HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 21384500 05708296219339

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female