BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 16944333 · Received May 17, 2023

    Report

    Report Number
    3005650109-2023-00066
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    April 9, 2023
    Report Date
    June 15, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296147113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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. DEVICE INVESTIGATION, CLINICAL ASSESSMENT AND RISK REGISTER CONCLUSION PENDING, WILL BE SUBMITTED ON COMPLETION. THIS IS AN INITIAL REPORT. (B)(6) 2023 TECHNICAL INVESTIGATION CONCLUDED: A DEVICE HISTORY RECORD REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. TRENDED CASE CONCLUDED: 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. DEVICE INVESTIGATION: A SHORT-CIRCUIT HAD FORMED INSIDE THE USB TYPE C CONNECTOR ON THE CHARGER. THE SHORT-CIRCUIT CAN BE FORMED BY THE CONTAMINANTS AT BOTTOM OF THE CONNECTOR. BUT SIGNS OF WEAR AND TEAR ARE ALSO PRESENT. THE SHORT-CIRCUIT WAS CREATED BY A LOW-OHMIC CONNECTION FROM VBUS TO GROUND. THE SHORT-CIRCUIT WILL EMIT HEAT WHEN THE POWER SUPPLY IS CONNECTED. THE POWER SUPPLY USED WITH THE CHARGER WAS NON-GN EQUIPMENT, THE CABLE USED WAS GN EQUIPMENT. THE POWER SUPPLY USED IS "KA1517-0501500EUU' FROM [?]SHENZHEN KEYU POWER SUPPLY TECHNOLOGY CO.,LTD'. THE POWER SUPPLY WAS RATED 7.5 WATT AND COULD THEREFORE DISSIPATE MORE HEAT INTO THE CONNECTOR. THE NON-GN AC-ADAPTER, HAS FAILED. THIS FAILURE HAS A PART IN, WHAT THE USER DESCRIBES AS TRIGGERING THE FIRE ALARM. THE AC-ADAPTER SHOULD UNDER A STRESS SITUATION NOT FAIL, LIKE THE ONE USED HERE. THE CLINICAAL INVESTIGATION CONCLUDED: IT HAS BEEN REPORTED THAT "CHARGER, CABLE AND ADAPTER MELTED AT NIGHT DURING CHARGING AND TRIGGERED THE FIRE ALARM'. ORIGINAL CHARGER AND CABLE USED, BUT ADAPTER IS NOT ORIGINAL. R&D INVESTIGATION CONCLUDED THAT THE ORIGINAL AC-ADAPTER SHOULD UNDER A STRESS SITUATION NOT FAIL, LIKE THE UNORIGINAL ONE USED HERE. NO PERSONAL HARM OR PROPERTY DAMAGE REPORTED. 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 RISK REGISTER CONCLUSION 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. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A FINAL REPORT.

    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. DEVICE INVESTIGATION, CLINICAL ASSESSMENT AND RISK REGISTER CONCLUSION PENDING, WILL BE SUBMITTED ON COMPLETION. THIS IS AN INITIAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED, CHARGER, CABLE AND ADAPTER MELTED AT NIGHT (B)(6)2023 - (B)(6) 2023) DURING CHARGING AND TRIGGERED THE FIRE ALARM. IT DID NOT CAUGHT FIRE. IT HAPPENED TO THE CHARGER. WHILE PLUGGED TO THE ELECTRIC SYSTEM. UNORIGINAL EQUIPMENT WAS USED. NO HARM OR PROPERTY DAMAGE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED, CHARGER, CABLE AND ADAPTER MELTED AT NIGHT ((B)(6) 2023) DURING CHARGING AND TRIGGERED THE FIRE ALARM. IT DID NOT CAUGHT FIRE. IT HAPPENED TO THE CHARGER. WHILE PLUGGED TO THE ELECTRIC SYSTEM. UNORIGINAL EQUIPMENT WAS USED. NO HARM OR PROPERTY DAMAGE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501106 GN RESOUND HEARING AID, , AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 20472100 05708296147113

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male