BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 17237483 · Received June 30, 2023

    Report

    Report Number
    3005650109-2023-00086
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    June 1, 2023
    Report Date
    July 25, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296147113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REFERENCE: (B)(4). INVESTIGATION IS ONGOING, A FINAL REPORT WILL BE SUBMITTED ONCE INVESTIGATION IS COMPLETE. THIS IS AN INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REFERENCE: (B)(4). INVESTIGATION IS ONGOING, A FINAL REPORT WILL BE SUBMITTED ONCE INVESTIGATION IS COMPLETE. THIS IS AN INITIAL REPORT. (B)(6) 2023. TECHNICAL INVESTIGATION CONCLUDED: A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE TESTING OF ACTUAL DEVICE CONCLUDED: AN APOLLO 5.1 C-1 WAS RETURNED DUE TO INITIALLY NOT CHARGING AND UPON RESET, GOT VERY HOT. VISUAL INSPECTION SHOWS ALL COMPONENTS ARE IN FINE CONDITION, NO SIGNS OF DAMAGE ANYWHERE ON THE CHARGER. A TEST WAS PERFORMED TO SEE IF THE OVERHEATING COULD BE RECREATED. NO OVERHEATING WAS OBSERVED FOR ANY OF THE COMPONENTS OF THE PCB OF THE CHARGER WAS OBSERVED. CHARGER PERFORMED NOMINALLY, BEING ABLE TO CHARGE THE BATTERY OF THE CHARGER. CLINICAL EVALUATION: IT HAS BEEN REPORTED THAT THE CHARGER STOPPED WORKING, IT WAS RESET AFTER WHICH IT STARTED WORKING AGAIN. HOWEVER, IT GOT HOT VERY FAST. CHARGER WAS THEN REPLACED. NO MENTION OF HARM TO THE USER, OR THEIR PROPERTY. RISK ASSESSMENT CONCLUDED: OVERHEATING ISSUES ARE KNOWN ABOUT AND THEIR RISK ASSESSED AND DEEMED TO BE ACCEPTABLE. BASED ON THE RESULT OF DEVICE INVESTIGATION, WHERE NO PRODUCT PROBLEM WAS FOUND AND NO HARM WAS REPORTED BY THE USER, THIS EVENT IS NOW DETERMINED TO BE NON-REPORTABLE.

    Description of Event or Problem · 0

    ON AN UNKNOWN DATE (BEST GUESS IS SOMETIME IN (B)(6) 2023), IT WAS REPORTED ON (B)(6) 2023 THAT CHARGER STOPPED WORKING. IT WAS RESET AND STARTED WORKING AGAIN BUT GOT VERY HOT VERY FAST. IMAGES OBTAINED OF THE DEVICE SHOWED A MELTED CHARGER PORT. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY, AND NO MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS EXPECTED.

    Description of Event or Problem · 0

    ON AN UNKNOWN DATE (BEST GUESS IS SOMETIME IN (B)(6) 2023), IT WAS REPORTED ON (B)(6) 2023 THAT CHARGER STOPPED WORKING. IT WAS RESET AND STARTED WORKING AGAIN BUT GOT VERY HOT VERY FAST. IMAGES OBTAINED OF THE DEVICE SHOWED A MELTED CHARGER PORT. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY, AND NO MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS EXPECTED. (B)(6) 2023. IMAGES RECEIVED WERE REVIEWED BY DEVICE INVESTIGATORS AND DETERMINED THAT THE CHARGER PORT WAS NOT MELTED, INSTEAD IT SHOWED SIGNS OF WEAR AND TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422961 GN RESOUND HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, OSM GN HEARING A/S 20472100 05708296147113

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown