BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GN RESOUND

    MDR report key: 10501077 · Received September 8, 2020

    Report

    Report Number
    3005650109-2020-00032
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    August 10, 2020
    Report Date
    September 17, 2020
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05704819233226
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLINICAL EVALUATION BELOW THIS CASE HAS BEEN EVALUATED NOT TO BE REPORTABLE AND WILL BE DOWNGRADED TO A NORMAL COMPLAINT. THERE IS NO SERIOUS INJURY AND THE TESTED MALFUNCTION IS NOT LIKELY TO CAUSE OR CONTRIBUTE SHOULD IT RECUR. THE CASE HAS BEEN REVIEWED FROM A CLINICAL PERSPECTIVE. CUSTOMER REPORTED: THE HEARING AID HAD A LOUD STATIC SOUND. THE END USER COULD NOT WEAR IT. THE SOUND WAS REPORTED PAINFUL, BUT HEARING AID WAS TAKEN OUT IMMEDIATELY. EA INVESTIGATION RESULTS: THE STATIC NOISE IS CAUSED BY A FAULTY FRONT MICROPHONE. THIS IS AMPLIFIED ACCORDING TO PRESCRIBED GAIN. THE RESULTING OUTPUT DOES NOT EXCEED 100 DB SPL (MEASURED IN 2CC) IN ANY OF THE PROGRAMS. CLINICAL EVALUATION: THE CLINICAL EVALUATION FOR THE DEVICE FAMILY DOES EVALUATE LOUD SOUNDS AND THIS IS ADDRESSED IN THE RISK ANALYSIS AND MITIGATED TO AN ACCEPTABLE LIMIT BY BUILT-IN PROTECTIVE MEASURES IN THE DEVICE DESIGN. EA INVESTIGATION SHOWS THAT THE STATIC NOISE IS A RESULT OF A FAULTY FRONT MICROPHONE, BUT THAT THE RESULTING OUTPUT DOES NOT EXCEED 100 DB SPL. CLINICAL CONCLUSION ON THE CASE IS THAT EVEN THOUGH UNPLEASANT, IT IS EVALUATED UNLIKELY THAT SHORTER EXPOSURE OF THIS OUTPUT LEVEL WOULD CAUSE HARM TO RESIDUAL HEARING.

    Description of Event or Problem · 0

    AS REPORTED BY THE LOCAL HEARING AID DEALER: AID HAS EXTREMELY LOUD STATIC, CLIENT CANNOT WEAR AID. HAPPENED IN PATIENT'S HOME. A LOUD STREAKING STATIC SOUND. LOUD STREAKING STATIC SOUND COMING FROM AID. PAINFUL TO PATIENT. BUT SHE TOOK AID OFF RIGHT AWAY. WE HAVE PREVIOUSLY SENT AN INITIAL REPORT, WHY THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    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 BY THE LOCAL HEARING AID DEALER: AID HAS EXTREMELY LOUD STATIC, CLIENT CANNOT WEAR AID. HAPPENED IN PATIENT'S HOME. A LOUD STREAKING STATIC SOUND. LOUD STREAKING STATIC SOUND COMING FROM AID. PAINFUL TO PATIENT. BUT SHE TOOK AID OFF RIGHT AWAY. 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
    966609 GN RESOUND VO588-DW,VERSO 5 OSM GN HEARING A/S VO588-DW,VERSO 5,GN RESOUND 05704819233226

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention