BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 19947501 · Received August 9, 2024

    Report

    Report Number
    3005650109-2024-00066
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 11, 2024
    Report Date
    August 9, 2024
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# (B)(4). MANUFACTURER'S INVESTIGATION: RECEIVER HAS BEEN RETURNED TO THE MANUFACTURER. THE FAULT IS LINKED TO A TRENDED CASE. HOWEVER, IT IS NOT POSSIBLE TO IDENTIFY HARDWARE DETAILS OF THE RECEIVER. LIKELY DUE TO WEAR AND TEAR. TRENDED CASE DEVICE INVESTIGATION CONCLUSION: R&D CONCLUDES THAT THE REAR HOUSING HAS TOO LITTLE GLUE TO KEEP HOUSING AND RECEIVER PARTS ADHERED TOGETHER, THEREBY CAUSING THE REAR HOUSING AND RECEIVER TO SEPARATE. CAPA HAS BEEN INITIATED TO IMPROVE MANUFACTURING PROCESS. THE CLINICAL INVESTIGATION CONCLUDED: IT WAS REPORTED THAT THE RECEIVERS COME APART RIGHT AT THE END OF THE RECEIVER "BOX". CUSTOMER REPORTS THAT PATIENT REMOVES THE HEARING AIDS "GENTLY" FROM HIS EARS. HE DOES NOT USE ANY SOLVENTS, LIQUIDS ETC TO CLEAN THE AIDS OR RECEIVERS. RECEIVER PART WAS NOT STUCK IN THE EAR AND DID NOT REQUIRE REMOVAL. NO HARM REPORTED. CLINICAL CONCLUSION IS THAT THE DETACHED RECEIVER HAS NOT CAUSED HARM TO THE PATIENT AND NO MEDICAL TREATMENT WAS PRESCRIBED. CLINICAL EVALUATION ACCORDING TO CLINICAL EVALUATION REPORT: 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: BASED ON THE INFO THIS APPEARS TO BE A KNOWN RISK COVERED BY EXISTING CAPA. ALL RESULTING ACTIONS ARE CONTAINED WITHIN THE CAPA WHICH INCLUDES ASSESSMENT OF RISKS AND ASSOCIATED UPDATES. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A COMBINED (INITIAL AND FINAL) REPORT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT HEARING CARE PROFESSIONAL RECEIVED A CALL FROM THE USER ON (B)(6) 2024. THE EXACT DATE OF THE EVENT IS UNKNOWN. IT HAS BEEN REPORTED THAT THE RECEIVERS BROKE RIGHT WHERE THE WIRE MEETS THE RECEIVER "BOX". NO OBJECT WAS STUCK IN THE EAR, NO HARM OR INJURY REPORTED. HEARING CARE PROFESSIONAL WILL REPLACE THE RECEIVER ONCE THE END USER VISITS THE OFFICE. NO FURTHER FOLLOW UP INFORMATION EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1646566 GN RESOUND HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male