BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 19816137 · Received July 24, 2024

    Report

    Report Number
    3005650109-2024-00064
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    June 1, 2024
    Report Date
    August 22, 2024
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# SF (B)(4). MANUFACTURER'S INVESTIGATION: MANUFACTURER'S INVESTIGATION IS ONGOING. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION THIS IS AN INITIAL REPORT. (B)(6) 2024 TECHNICAL INVESTIGATION CONCLUDED: A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. THE CLINICAL INVESTIGATION CONCLUDED: IT HAS BEEN REPORTED THAT THE USER HAS THE RECEIVER TIP OF THEIR HEARING AID COME APART. USER HAD THE DEVICE FOR LESS THAN A YEAR. THE RECEIVER WAS AN MP RECEIVER. IT IS UNKNOWN IF THE BREAK OF THE RECEIVER HAPPENED WHILE INSIDE THE EAR, BUT IT HAS BEEN REPORTED THAT IT DID NOT REQUIRE REMOVAL. THERE WAS NO HARM TO THE USER DUE TO THIS INCIDENT. CLINICAL CONCLUSION IS THAT THE DETACHED RECEIVER HAS NOT CAUSED HARM TO THE PATIENT. CLINICAL EVALUATION ACCORDING TO 0378040 CLIN EVAL PLAN&RPT,HA&TSG AND 0378100 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 HEARING CARE PROFESSIONAL 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 TRENDED CASE 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. INVESTIGATION AND CORRECTIVE ACTIONS ARE CONTAINED WITHING AN EXISTING CAPA, EFFECTIVENESS REVIEW HAS BEEN PERFORMED AND ACCEPTED. THE CAPA IS CLOSED. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    ESTIMATED DATE OF INCIDENT ON (B)(6) 2024. IT WAS REPORTED THAT THE USER HAD THE RECEIVER TIP COME APART. THE RECEIVER LEVEL WAS MEDIUM-POWER. NO HARM TO THE USER FOLLOWING THE INCIDENT. NO OBJECT GOT STUCK IN THE EAR.

    Description of Event or Problem · 0

    ESTIMATED DATE OF INCIDENT (B)(6) 2024 IT WAS REPORTED THAT THE USER HAD THE RECEIVER TIP COME APART. THE RECEIVER LEVEL WAS MEDIUM-POWER. NO HARM TO THE USER FOLLOWING THE INCIDENT. NO OBJECT GOT STUCK IN THE EAR. (B)(6) 2024 NO FURTHER FOLLOW UP HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356881 GN RESOUND HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown