BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 15452954 · Received September 20, 2022

    Report

    Report Number
    3005650109-2022-00035
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    August 22, 2022
    Report Date
    October 18, 2022
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05704819289933
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SF: (B)(4). A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. IT HAS BEEN REPORTED- NOT ENOUGH INFORMATION HOW THE HA GOT MELTED IN THE DRY JAR. AID PHYSICALLY MELTED AND BROKEN INTO PIECES. TECHNICAL INVESTIGATION: MOST DRYING JARS CAN DRY AIDS IN SURROUNDINGS UP TO 50-60 DEGREES. IF THE HEARING AIDS ARE TURNED OFF, IT IS FINE TO USE DRY JARS. A DRY BOX CAN BE USED FOR ALL TYPES OF GN HEARING AIDS.IT IS SUSPECTED THAT THE AIDS WERE LEFT IN THE DRY BOX SUBJECTED TO SURROUNDINGS WITH EXCESSIVE HEAT. THIS IS AN INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    (B)(6). A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. IT HAS BEEN REPORTED- NOT ENOUGH INFORMATION HOW THE HA GOT MELTED IN THE DRY JAR. AID PHYSICALLY MELTED AND BROKEN INTO PIECES. TECHNICAL INVESTIGATION: MOST DRYING JARS CAN DRY AIDS IN SURROUNDINGS UP TO 50-60 DEGREES. IF THE HEARING AIDS ARE TURNED OFF, IT IS FINE TO USE DRY JARS. A DRY BOX CAN BE USED FOR ALL TYPES OF GN HEARING AIDS.IT IS SUSPECTED THAT THE AIDS WERE LEFT IN THE DRY BOX SUBJECTED TO SURROUNDINGS WITH EXCESSIVE HEAT. CLINICAL EVALUATION OF THE EVENT: CASE INFORMATION STATES THAT THE DEVICES MELTED WHILE PLACED IN A DRYING JAR. THE JAR IS NOT A GN HEARING PRODUCT, AND THE PATIENT REPORTS THAT THE HEATING ELEMENT IN THE DRYING JAR MAY HAVE CAUSED THE MELTING. NO PATIENT HARM WAS REPORTED, AS THE DEVICES WERE IN THE DRYING JAR AND NOT IN THE PATIENT'S EARS. DEVICE USER GUIDE HAS A WARNING HOW TO DRY THE DEVICES. RISK ANALYSIS ALREADY INCLUDED, THE RESIDUAL RISK AFTER THE RISK CONTROL MEASURE(S) IS ACCEPTABLE. THIS IS A FINAL REPORT. NO FURTHER INFORMATION IS EXPECTED.

    Description of Event or Problem · 0

    SF: (B)(4). IT WAS REPORTED- AIDS PUT IN DRY JAR AND MELTED. CUSTOMER VERIFIED THE JAR WAS NOT RESOUND BRAND. THEY BELIEVE THE HEAT ELEMENT IN THE JAR CAUSED THE MELTING AND THEREFORE WAS NOT RELATED TO THE RESOUND AIDS, BUT NO SPECIFIC INVESTIGATION WAS DONE' THE CURRENT INFORMATION INDICATES NEED FOR IMMEDIATE REPORTING. BASED ON THE AVAILABLE INFORMATION, THE EVENT/ INCIDENT DID LEAD TO, OR MIGHT LED TO, DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR. THIS IS AN INITIAL REPORT.

    Description of Event or Problem · 0

    (B)(6). IT WAS REPORTED- AIDS PUT IN DRY JAR AND MELTED. CUSTOMER VERIFIED THE JAR WAS NOT RESOUND BRAND. THEY BELIEVE THE HEAT ELEMENT IN THE JAR CAUSED THE MELTING AND THEREFORE WAS NOT RELATED TO THE RESOUND AIDS, BUT NO SPECIFIC INVESTIGATION WAS DONE'. THE CURRENT INFORMATION INDICATES NEED FOR REPORTING. BASED ON THE AVAILABLE INFORMATION, THE EVENT/ INCIDENT DID LEAD TO, OR MIGHT LED TO, DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR. THIS IS A FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2698693 GN RESOUND HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 19706708 05704819289933

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown