BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN HEARING A/S

    MDR report key: 17238030 · Received June 30, 2023

    Report

    Report Number
    3005650109-2023-00087
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    May 1, 2023
    Report Date
    July 27, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296147137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF: (B)(4). TRENDED CASE ANALYSIS: THE CONNECTOR IS BROKEN, PROBABLY BECAUSE THE USER HAS (NOT INTENTIONALLY) MISUSED IT, WHILE INSERTING THE CABLE. IF THE CABLE HAS BEEN SLIGHTLY OUT OF SPECIFICATION THAT COULD HAVE HAD A NEGATIVE EFFECT ON THIS. THIS HAS CAUSED A LOW OHMIC CONNECTION IN THE CABLE CONNECTOR - ALMOST A SHORT CIRCUIT - THAT WILL EMIT HEAT WHEN THE CABLE IS INSERTED INTO THE WALL CHARGER, CAUSING UP TO THE RATED 5 W OF THE WALL CHARGER TO BE DISSIPATED INSIDE THE CONNECTOR. MICRO USB IS A VERY WELL KNOWN AND USED STANDARD BUT CAN MECHANICALLY BREAK DOWN. IT HAS BEEN REPORTED THAT -CHARGER IS CLEARLY MELTED AT THE POINT OF CONNECTION TO THE POWER CORD. PATIENT ALSO BURNED THEIR FINGER HOWEVER IT DID NOT REQUIRE MEDICAL ATTENTION'. ORIGINAL ACCESSORIES WERE USED. THE CHARGERS HAVE BEEN TESTED ACCORDING TO APPLICABLE SAFETY STANDARDS. THESE RISKS ARE REDUCED AS FAR AS POSSIBLE AND THE PROBABILITY OF OCCURRENCE OF THESE EVENTS IS CONSIDERED VERY LOW. IN CASE OF MOISTURE, SWEAT OR DIRT IN THE CONNECTOR, THERE CAN BE HIGH TEMPERATURES INSIDE THE CONNECTOR DUE TO POWER DISSIPATION WHEN CONNECTED TO THE CHARGER PLUG. THERE CAN BE MELTING OF THE PLASTIC AROUND THE CONNECTOR AND IS VISIBLE TO THE NAKED EYE. IT IS HIGHLY UNLIKELY THAT THE USER WOULD TOUCH IN CASE THERE APPEARS TO BE MELTING OR HIGH TEMPERATURES. IN THE UNLIKELY EVENT OF THE USER TOUCHING THIS OVERHEATED DEVICE, IT CAN LEAD TO SUPERFICIAL OR MINOR INJURY THAT WOULD IN MOST CASES REQUIRE NO MEDICAL INTERVENTION. 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 CONCLUSION HEREIN ARE SUFFICIENT. THIS IS AN INITIAL REPORT. A FINAL REPORT WILL BE SUBMITTED ON COMPLETION OF RISK ASSESSMENT AND DHR FINDINGS.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF: # (B)(4). TRENDED CASE ANALYSIS: THE CONNECTOR IS BROKEN, PROBABLY BECAUSE THE USER HAS (NOT INTENTIONALLY) MISUSED IT, WHILE INSERTING THE CABLE. IF THE CABLE HAS BEEN SLIGHTLY OUT OF SPECIFICATION THAT COULD HAVE HAD A NEGATIVE EFFECT ON THIS. THIS HAS CAUSED A LOW OHMIC CONNECTION IN THE CABLE CONNECTOR - ALMOST A SHORT CIRCUIT - THAT WILL EMIT HEAT WHEN THE CABLE IS INSERTED INTO THE WALL CHARGER, CAUSING UP TO THE RATED 5 W OF THE WALL CHARGER TO BE DISSIPATED INSIDE THE CONNECTOR. MICRO USB IS A VERY WELL KNOWN AND USED STANDARD BUT CAN MECHANICALLY BREAK DOWN. IT HAS BEEN REPORTED THAT -CHARGER IS CLEARLY MELTED AT THE POINT OF CONNECTION TO THE POWER CORD. PATIENT ALSO BURNED THEIR FINGER HOWEVER IT DID NOT REQUIRE MEDICAL ATTENTION'. ORIGINAL ACCESSORIES WERE USED. THE CHARGERS HAVE BEEN TESTED ACCORDING TO APPLICABLE SAFETY STANDARDS. THESE RISKS ARE REDUCED AS FAR AS POSSIBLE AND THE PROBABILITY OF OCCURRENCE OF THESE EVENTS IS CONSIDERED VERY LOW. IN CASE OF MOISTURE, SWEAT OR DIRT IN THE CONNECTOR, THERE CAN BE HIGH TEMPERATURES INSIDE THE CONNECTOR DUE TO POWER DISSIPATION WHEN CONNECTED TO THE CHARGER PLUG. THERE CAN BE MELTING OF THE PLASTIC AROUND THE CONNECTOR AND IS VISIBLE TO THE NAKED EYE. IT IS HIGHLY UNLIKELY THAT THE USER WOULD TOUCH IN CASE THERE APPEARS TO BE MELTING OR HIGH TEMPERATURES. IN THE UNLIKELY EVENT OF THE USER TOUCHING THIS OVERHEATED DEVICE, IT CAN LEAD TO SUPERFICIAL OR MINOR INJURY THAT WOULD IN MOST CASES REQUIRE NO MEDICAL INTERVENTION. 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 CONCLUSION HEREIN ARE SUFFICIENT. THIS IS AN INITIAL REPORT. A FINAL REPORT WILL BE SUBMITTED ON COMPLETION OF RISK ASSESSMENT AND DHR FINDINGS. (B)(6) 2023. CORRECTION: D9 - UNTICKED "DEVICE RECEIVED" AND DELETED "DATE RECEIVED" - -DEVICE HAS NOT BEEN RECEIVET BY MANUFACTURER. A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE MANUFACTURERS INVESTIGATION IS FINAL,. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE CHARGER OVERHEATED AND IS TOTALLY MELTED WITH BLACK RESIDUE COMING OUT OFF IT, CHARGER IS CLEARLY MELTED AT THE POINT OF CONNECTION TO THE POWER CORD. PATIENT ALSO BURNED THEIR FINGER HOWEVER IT DID NOT REQUIRE MEDICAL ATTENTION. THIS IS AN INITIAL REPORT.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE CHARGER OVERHEATED AND IS TOTALLY MELTED WITH BLACK RESIDUE COMING OUT OFF IT, CHARGER IS CLEARLY MELTED AT THE POINT OF CONNECTION TO THE POWER CORD. PATIENT ALSO BURNED THEIR FINGER HOWEVER IT DID NOT REQUIRE MEDICAL ATTENTION. THIS IS AN INITIAL REPORT. 27JUL2023 NO FURTHER FOLLOW UP HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262837 GN HEARING A/S HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 20863700 05708296147137

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention