BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOUND

    MDR report key: 10199575 · Received June 26, 2020

    Report

    Report Number
    3005650109-2020-00018
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    June 24, 2020
    Report Date
    August 17, 2020
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    1. INITIAL REPORT: THE PERCEIVED LOUD SOUND LEVEL OF THE DEVICE CAN POTENTIALLY HARM THE REMAINING HEARING OF THE PATIENT. NO INDICATIONS OF ANY SUCH HARM IS PROVIDED IN THE COMPLAINT, BUT IT CANNOT BE RULED OUT. THE DEVICE IS EQUIPPED WITH A HIGH POWER RECEIVER. WE WILL NOT BE ABLE TO FINALIZE INVESTIGATION IN TIME FOR THE 30 DAY TIME LIMIT, WHY THIS IS AN INITIAL REPORT. 2. FOLLOW-UP/FINAL REPORT: THE CASE HAS BEEN DECIDED TO BE NON-REPORTABLE. CASE WILL BE DOWNGRADED AS WE HAVE ATTEMPTED SEVERAL GOOD FAITH EFFORTS TO CONTACT THE CUSTOMER FOR MORE INFORMATION WITH NO LUCK. IT HAS PROVEN IMPOSSIBLE TO HAVE THE HEARING AIDS RETURNED FOR INVESTIGATION (NOR THE SO-CALLED NOAH-FILE WITH FITTING INFORMATION) AND TO HAVE THE DESCRIPTION CLARIFIED (RE. HOW CAN A SOUND BE HOT). THERE IS ALSO NOTHING IN THE CASE THAT INDICATES THAT ANY HARM WAS INFLICTED TO THE USER. THE INTERNAL INITIAL REPORTABILITY QUESTIONNAIRE WAS ONLY TRIGGERED DUE TO ITS A HP DEVICE, WHICH WILL BE DOWNGRADED TO A NORMAL COMPLAINT DUE TO THE LACK OF INFORMATION.

    Description of Event or Problem · 0

    AS REPORTED: FORTE - LOUD SOUND THE PROGRAMMING ON THIS AID IS VERY LOUD AND HOT. 10-B210582 INTERPRETATION: THE PERCEIVED LOUD SOUND LEVEL OF THE DEVICE CAN POTENTIALLY HARM THE REMANINING HEARING OF THE PATIENT. NO INDICATIONS OF ANY SUCH HARM IS PROVIDED IN THE COMPLAINT, BUT IT CANNOT BE RULED OUT. THE DEVICE IS EQUIPPED WITH A HIGH POWER RECEIVER. WE WILL NOT BE ABLE TO FINALIZE INVESTIGATION IN TIME FOR THE 30 DAY TIME LIMIT, WHY THIS IS AN INITIAL REPORT. PREVIOUSLY AN INITIAL REPORT HAS BEEN SENT - THIS IS THE FOLLOW-UP/FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PERCEIVED LOUD SOUND LEVEL OF THE DEVICE CAN POTENTIALLY HARM THE REMAINING HEARING OF THE PATIENT. NO INDICATIONS OF ANY SUCH HARM IS PROVIDED IN THE COMPLAINT, BUT IT CANNOT BE RULED OUT. THE DEVICE IS EQUIPPED WITH A HIGH POWER RECEIVER. WE WILL NOT BE ABLE TO FINALIZE INVESTIGATION IN TIME FOR THE 30 DAY TIME LIMIT, WHY THIS IS AN INITIAL REPORT.

    Description of Event or Problem · 1

    AS REPORTED: FORTE - LOUD SOUND. THE PROGRAMMING ON THIS AID IS VERY LOUD AND HOT. 10-B210582. INTERPRETATION: THE PERCEIVED LOUD SOUND LEVEL OF THE DEVICE CAN POTENTIALLY HARM THE REMAINING HEARING OF THE PATIENT. NO INDICATIONS OF ANY SUCH HARM IS PROVIDED IN THE COMPLAINT, BUT IT CANNOT BE RULED OUT. THE DEVICE IS EQUIPPED WITH A HIGH POWER RECEIVER. WE WILL NOT BE ABLE TO FINALIZE INVESTIGATION IN TIME FOR THE 30 DAY TIME LIMIT, WHY THIS IS AN INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663884 RESOUND FORTE 8 OSM GN HEARING A/S FT888-DWH,FORTE 8,GN RESOUND

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability