BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 17708503 · Received September 8, 2023

    Report

    Report Number
    3005650109-2023-00130
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    August 10, 2023
    Report Date
    November 10, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# SF (B)(6) MANUFACTURER'S INVESTIGATION IS ONGOING, A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION. THIS IS AN INITIAL REPORT. (B)(6)2023 TRENDED CASE DEVICE INVESTIGATION CONCLUDED: - 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. ROOT CAUSE: 1.RELIABILITY OF GLUING STRENGTH WAS NOT VERIFIED. 2.THE FAILURE MODE WAS NOT RECOGNIZED AT DESIGN STAGE CLINICAL EVALUATION OF THE EVENT: IT WAS REPORTED THAT THE RECEIVER BROKE OFF AT BLUE END OF IT WITH DOME AND GOT STUCK IN PATIENTS' EAR. PATIENTS' FAMILY MEMBER WAS ABLE TO PULL IT OUT. NO HARM TO THE PATIENT REPORTED. NO MEDICAL ATTENTION WAS SOUGHT. CLINICAL CONCLUSION IS THE EVENT DID NOT CAUSE HARM TO THE PATIENT. 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 CONCLUSION REFERENCE: THIS RISK IS EVALUATED IN THE RISK ANALYSIS AND IS DEEMED TO BE ACCEPTABLE. A CAPA HAS BEEN RAISED COVERING THE INCIDENT. MANUFACTURE'S INVESTIGATION IS FINAL. THIS IS A FINAL REPORT. NO FURTHER INFORMATION IS EXPECTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    (B)(6)2023 IT WAS REPORTED NO HARM TO PEOPLE OR PROPERTY REPORTED: JABRA RECEIVER BROKE OFF AT BLUE END OF IT WITH DOME AND GOT STUCK IN USER'S EAR. HIS WIFE WAS ABLE TO PULL IT OUT. IT IS UNKNOWN IF THE HEARING AID WAS USED WITH A SPORTS LOCK. THE EVENT DIDN'T CAUSE ANY HARM TO THE USER. NO FUIRTHER FOLLOW UP EXPECTED. HEARING CARE PROVIDER HAS NOT GIVEN ITEM NUMBER OR SERIAL NUMBER.

    Description of Event or Problem · 0

    ON (B)(6) 2023 IT WAS REPORTED NO HARM TO PEOPLE OR PROPERTY REPORTED: JABRA RECEIVER BROKE OFF AT BLUE END OF IT WITH DOME AND GOT STUCK IN USER'S EAR. HIS WIFE WAS ABLE TO PULL IT OUT. IT IS UNKNOWN IF THE HEARING AID WAS USED WITH A SPORTS LOCK. THE EVENT DIDN'T CAUSE ANY HARM TO THE USER. NO FUIRTHER FOLLOW UP EXPECTED. HEARING CARE PROVIDER HAS NOT GIVEN ITEM NUMBER OR SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112576 GN RESOUND HEARING AID, , AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 Male