BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELTONE

    MDR report key: 15864265 · Received November 25, 2022

    Report

    Report Number
    3005650109-2022-00072
    Event Type
    Malfunction
    Date Received
    November 25, 2022
    Date of Event
    October 10, 2022
    Report Date
    November 25, 2022
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296086962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF#: (B)(4). TECHNICAL INVESTIGATION CONCLUDED: A DEVICE HISTORY RECORD REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. TRENDED CASE INVESTIGATION CONCLUDED: THE OUTER SHELL HAS CLEAR SIGNS OF HEAT FROM WITHIN. THE OUTER SHELL IS GREATLY DAMAGED. WHICH POINTS TO A HIGH AMOUNT OF ENERGY BEING RELEASED. THE ZINC-AIR BATTEY THAT IS POWERING THIS TYPE OF HEARING AID IS NOT CAPABLE OF DELIVERING THE KIND OF ENERGY THAT HAS CAUSED THIS DAMAGE. FURTHERMORE, A SHORT CIRCUIT TEST HAS BEEN CONDUCTED THAT SHOWS THE TEMPERATURE RISE THAT CAN BE EXPECTED, IF A SAFETY FAILURE WAS TO OCCUR. THE TEMPERATURE RISE WAS WITHIN 2-3 DEGREES. THERE IS A HIGH INDICATION THAT THE DEVICE HAS BEEN EXPOSED TO A MICROWAVE OVEN. THIS IS CONFIRMED WHEN COMPARING THE DEVICE TO TWO REFERENCE DEVICES THAT HAVE BEEN EXPOSED TO A MICROWAVE OVEN. THEY SHOW SIMILAR SIGNS OF DAMAGE. THE CLINICAL INVESTIGATION CONCLUDED: END-USER REPORTED MELTING OF THE CASE OF ONE OF HIS HEARING AIDS. ZINC AIR BATTERIES CANNOT CAUSE SIGNIFICANT DEVICE OVERHEATING AND IT IS VERY UNLIKELY THAT THE MELTING OF THE CASE WAS CAUSED BY INTERNAL HEAT. THE DAMAGE IS CONSISTENT WITH WHAT IS SEEN WHEN DEVICES ARE PLACED IN MICROWAVE OR OVEN. THE USER GUIDE INCLUDES A CAUTION NOT TO USE OVEN, MICROWAVE OVEN OR OTHER HEATING EQUIPMENT FOR DRYING OF HEARING AIDS. CLINICAL CONCLUSION ON THE CASE IS THAT THE EVENT IS LIKELY A RESULT OF USER PUTTING DEVICE IN THE MICROWAVE, POSSIBLY TO DRY OUT THE DEVICE, WHICH THE USER IS DIRECTLY TOLD NOT TO DO. THE CLINICAL EVALUATION FOR THE DEVICE FAMILY EVALUATES OVERHEATING OF HEARING AIDS. 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. THIS IS A COMBINED INITIAL AND FINAL REPORT.

    Description of Event or Problem · 0

    ON 10-OCT-2022 IT WAS REPORTED THE HEARING AID GOT HOT AND MELTED THE SIDE OF THE CASING OF THE AID. IT IS CONCERNING A NON-RECHARGEABLE HEARING AID. THE USER WAS NOT HARMED. ORIGINAL EQUIPMENT WAS USED. NO FURTHER INFORMATION EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686796 BELTONE HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 20557205 05708296086962

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male