BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 15473967 · Received September 23, 2022

    Report

    Report Number
    3005650109-2022-00038
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Date of Event
    August 25, 2022
    Report Date
    October 21, 2022
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296145584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. THIS IS AN INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# SF (B)(4). A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. ADDITIONAL INFORMATION: DEVICE INVESTIGATION CONCLUSION: THERE IS SOME RESIDUES OF DIRT IN ONE OF THE DEVICES, THE OTHER SEEMS TO BE CLEAN INSIDE. THE IDENTIFICATION OF THE FOREIGN MATTER IS PENDING. BOTH DEVICES CAN BE CHARGED AND STARTS UP. THEY ARE IN WORKING CONDITIONS. ONE OF THE DEVICES (B)(6) HAS PASSED FINAL DEVICE TEST 15. APRIL 2019, THEN THE DEVICE HAD A SECOND FINAL DEVICE TEST ON 20. MAY 2021 BUT WITH A DIFFERENCE HYBRID FROM 8. SEPTEMBER 2020. THIS MUST BE DUE TO A REPAIR. ACCORDING TO THE PAPERS INCLUDED, A REPAIR HAS ALSO BEEN ORDERED ON 15. AUGUST 2022. ONE OF THE DEVICES HAS A RUN TIME ON THE DESK THAT EXCEEDS 16 HOURS - THIS IS ACCORDING TO SPECIFICATION. THE DEVICES (BATTERIES) ARE FOUND TO BE IN WORKING ORDER, LEAKAGE OF BATTERY FLUID SEEMS HIGHLY UNLIKELY. THE DEVICES (BATTERIES) ARE FOUND TO BE IN WORKING ORDER, LEAKAGE OF BATTERY FLUID SEEMS HIGHLY UNLIKELY. CLINICAL EVALUATION: BATTERY LEAKAGE CAN IN SOME CASES BE PREVENTED IF THE HEARING AIDS ARE DRIED OUT AFTER USE BY OPENING THE BATTERY DOOR. FURTHER, BATTERIES THAT ARE EXPIRED ARE MORE LIKELY TO LEAK. THE USER GUIDE INCLUDES RECOMMENDATIONS ON BOTH HEARING AID DRYING AND ONLY TO USE BATTERIES WITH A REMAINING SHELF LIFE OF ONE YEAR OR MORE. THE USER GUIDE CONTAINS INFORMATION ONLY TO USE QUALITY BATTERIES AS WELL AS RINSING WITH LUKEWARM WATER IF EXPOSED TO BATTERY LEAKAGE. RISK ANALYSIS ALREADY INCLUDED AND THE RESIDUAL RISK AFTER THE RISK CONTROL MEASURE(S) IS ACCEPTABLE. THE ABOVE INFORMATION INDICATES NO NEED FOR REPORTING. THE MALFUNCTION MAY NOT LEAD TO, OR MIGHT LED TO, DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR. THIS CASE IS CONSIDERED AS A SINGLE INCIDENT AND WILL BE INCLUDED IN REGULAR TRENDING. NO ACTIONS HAVE BEEN INITIATED BASED ON THIS INDIVIDUAL EVENT. THIS IS A FINAL REPORT. NO FURTHER INFORMATION IS EXPECTED.

    Description of Event or Problem · 0

    SF (B)(4). IT HAS BEEN REPORTED- BATTERIES ARE LEAKING FLUIDS INSIDE CASING. BASED ON THE AVAILABLE INFORMATION, THE EVENT IS CONSIDERED REPORTABLE AS THE MALFUNCTION MAY LEAD TO, OR MIGHT LED TO, DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR. THE PRODUCT HAS BEEN REPLACED. THIS IS AN INITIAL REPORT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED- BATTERIES ARE LEAKING FLUIDS INSIDE CASING. NO HARM TO USER. THE PRODUCT HAS BEEN REPLACED. THIS IS A FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2728791 GN RESOUND HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 20686320 05708296145584

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown