BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 15493452 · Received September 27, 2022

    Report

    Report Number
    3005650109-2022-00041
    Event Type
    Malfunction
    Date Received
    September 27, 2022
    Report Date
    September 27, 2022
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296145362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# SF (B)(4). FOLLOW UP: A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. PARENT CASE INVESTIGATION: THE RECHARGEABLE BATTERIES IN THE RESOUND LINX QUATTRO HEARING AIDS AND THE HEARING AID CHARGER ARE LITHIUM-ION BATTERIES. IT IS RECOMMENDED-AVOID STORING YOUR HEARING AIDS AND HEARING AIDS CHARGER NEAR SOURCES OF HEAT OR COLD. NB: IF YOUR LINX QUATTRO, BELTONE AMAZE OR PREZA 8 WITH DSW 1.0.45 OR HIGHER ARE GETTING WARM FOR A LONGER PERIOD OF TIME DURING CHARGING OR SHOW MUCH LESS THAN 16 HOURS BATTERY LIFE AFTER FULL CHARGING OF AT LEAST 3 HOURS, IT IS PROBABLY A DEFECT BATTERY IN ONE OF THE HI AND YOU HAVE TO SEND THE HI FOR SERVICE AND REPAIR. ALTHOUGH REPORTED - HEARING AID HEATED UP IN THE CHARGER SO BADLY THAT IT BURNT THE PATIENT'S FINGER WHEN SHE REMOVED FROM CHARGER ENOUGH TO TURN HER FINGER RED WHERE SHE MADE CONTACT. THIS HAS NOT BEEN CONFIRMED WITH PICTURES OR FURTHER INFORMATION. RISK WILL UPDATE TO INCLUDE WARNING/CAUTION TO THE USERS. CLINICAL CONCLUSION ON THE CASE IS THAT, EVEN THOUGH UNPLEASANT, RISK OF HIGH TEMPERATURE AND BURN ARE MITIGATED BY EXTENSIVE SAFETY TESTING ACCORDING TO STANDARDS ACCORDING TO MASTER RISK LIST. IT IS EVALUATED UNLIKELY THAT THE DEVICE IN FAILURE MODE WOULD CAUSE HARM, IF THE EVENT WAS TO REOCCUR, BECAUSE OF THE UNLIKELY EVENT OF CONTACTING THE DIFFICULT TO TOUCH LOCATION. RISK REGISTER WILL BE UPDATED TO INCLUDE WARNING/CAUTION TO THE USERS. BASED ON THE ABOVE INFORMATION, THE CASE IS CONSIDERED NOT REPORTABLE AS THE EVENT / INCIDENT DID NOT LEAD TO, OR MIGHT LED TO, DEATH OR A SERIOUS INJURY. H6: 4581 APPROPRIATE TERM/CODE NOT AVAILABLE USED SINCE THERE WAS NO CONFIRMATION OF THE REPORTED BURN. IT IS A FEMALE PATIENT. THIS IS A FINAL REPORT. NO FURTHER INFORMATION EXPECTED.

    Additional Manufacturer Narrative · 0

    (B)(4). A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. PARENT CASE INVESTIGATION: THE RECHARGEABLE BATTERIES IN THE RESOUND LINX QUATTRO HEARING AIDS AND THE HEARING AID CHARGER ARE LITHIUM-ION BATTERIES. IT IS RECOMMENDED-AVOID STORING YOUR HEARING AIDS AND HEARING AIDS CHARGER NEAR SOURCES OF HEAT OR COLD. NB: IF YOUR LINX QUATTRO, BELTONE AMAZE OR PREZA 8 WITH DSW 1.0.45 OR HIGHER ARE GETTING WARM FOR A LONGER PERIOD OF TIME DURING CHARGING OR SHOW MUCH LESS THAN 16 HOURS BATTERY LIFE AFTER FULL CHARGING OF AT LEAST 3 HOURS, IT IS PROBABLY A DEFECT BATTERY IN ONE OF THE HI AND YOU HAVE TO SEND THE HI FOR SERVICE AND REPAIR. ALTHOUGH REPORTED - HEARING AID HEATED UP IN THE CHARGER SO BADLY THAT IT BURNT THE PATIENT'S FINGER WHEN SHE REMOVED FROM CHARGER ENOUGH TO TURN HER FINGER RED WHERE SHE MADE CONTACT. THIS HAS NOT BEEN CONFIRMED WITH PICTURES OR FURTHER INFORMATION. THIS IS AN INITIAL REPORT.

    Description of Event or Problem · 0

    MANUFACTURER'S REF: SF (B)(4). IT HAS BEEN REPORTED- HEARING AID HEATED UP IN THE CHARGER SO BADLY THAT IT BURNT THE PATIENT'S FINGER WHEN SHE REMOVED FROM CHARGER ENOUGH TO TURN HER FINGER RED WHERE SHE MADE CONTACT. NO FURTHER INFORMATION AVAILABLE REGARDING PICTURES, TREATMENT, ETC. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    (B)(4). IT HAS BEEN REPORTED- HEARING AID HEATED UP IN THE CHARGER SO BADLY THAT IT BURNT THE PATIENT'S FINGER WHEN SHE REMOVED FROM CHARGER ENOUGH TO TURN HER FINGER RED WHERE SHE MADE CONTACT. NO FURTHER INFORMATION AVAILABLE REGARDING PICTURES, TREATMENT, ETC. THIS IS AN INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302114 GN RESOUND HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 20686204 05708296145362

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other