BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 16775430 · Received April 20, 2023

    Report

    Report Number
    3005650109-2023-00050
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    March 1, 2023
    Report Date
    July 13, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296156856
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF: #(B)(4). PRELIMINARY INVESTIGATION CONCLUDED THAT BOTH UNITS HAD BEEN PASSED THROUGH THE TEST PRIOR TO SHIPMENT AND NO ABNORMALITY CAPTURED THROUGHOUT THE PROCESS. BOTH UNITS WERE MANUFACTURED ON 21.07.2021 VIA DHR (B)(4) (2 YEARS AGO). IT HAS BEEN FOUND THAT THE BATTERY DOOR IS WEEK AND NEEDS THOROUGH INVESTIGATION. THE DEVICE INVESTIGATION IS STILL TO BE FINALISED. CLINICAL ASSESSMENT CONCLUSION IT IS REPORTED THAT 'PATIENTS BATTERY DOORS WILL NOT STAY CLOSED'. THIS CONCERNS BTE (BEHIND THE EAR) DEVICES AND THEREFORE THE RISK OF FOREIGN BODY IN THE EAR IS NOT APPLICABLE. DUE TO THE MISSING PART, THE BATTERY DOOR FOR THE HEARING AID WILL NOT STAY CLOSED AND THE DEVICE WILL NOT FUNCTION. CLINICAL CONCLUSION OF THE CASE IS THERE WAS NO POTENTIAL PATIENT HARM. THE USER GUIDE INCLUDES A WARNING STATING - INSTRUMENT USAGE BY CHILDREN OR MENTALLY CHALLENGED PERSONS SHOULD BE ALWAYS SUPERVISED TO ENSURE THEIR SAFETY. THE HEARING INSTRUMENT CONTAINS SMALL PARTS THAT COULD BE SWALLOWED BY CHILDREN. PLEASE BE MINDFUL NOT TO LEAVE CHILDREN UNSUPERVISED WITH THIS HEARING INSTRUMENT'. THE USER GUIDE ALSO INCLUDES A RECOMMENDATION TO IMMEDIATELY SEEK MEDICAL ATTENTION IF IT IS SWALLOWED. ADDITIONALLY, THE USER GUIDE STATES IF A HEARING AID IS BROKEN, DO NOT USE IT. CLINICAL EVALUATION ACCORDING TO (B)(4) CLIN EVAL PLAN&RPT,HA&TSG: HEARING AID POWERING IS A PRECONDITION FOR THE HEARING AID TO FUNCTION. THE RISKS ASSOCIATED WITH POWERING AND BATTERIES ARE REDUCED AS FAR AS POSSIBLE AND THE BENEFIT OF A HEARING AID OUTWEIGHS THESE RISKS. RISK ASSESSMENT: KNOWN RISK. MITIGATED. RISK DEEMED ACCEPTABLE. THIS IS A FOLLOW UP REPORT. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVSTIGATIONS ARE FINALIZED. THE CASE IS LATE AND A NC-02241 HAS BEEN FILED FOR THIS ERROR.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF: # (B)(4). PRELIMINARY INVESTIGATION CONCLUDED THAT BOTH UNITS HAD BEEN PASSED THROUGH THE TEST PRIOR TO SHIPMENT AND NO ABNORMALITY CAPTURED THROUGHOUT THE PROCESS. BOTH UNITS WERE MANUFACTURED ON 21.07.2021 VIA DHR WO21704318 (2 YEARS AGO). CLINICAL ASSESSMENT CONCLUSION: IT IS REPORTED THAT 'PATIENTS BATTERY DOORS WILL NOT STAY CLOSED'. THIS CONCERNS BTE (BEHIND THE EAR) DEVICES AND THEREFORE THE RISK OF FOREIGN BODY IN THE EAR IS NOT APPLICABLE. DUE TO THE MISSING PART, THE BATTERY DOOR FOR THE HEARING AID WILL NOT STAY CLOSED AND THE DEVICE WILL NOT FUNCTION. CLINICAL CONCLUSION OF THE CASE IS THERE WAS NO POTENTIAL PATIENT HARM. THE USER GUIDE INCLUDES A WARNING STATING - INSTRUMENT USAGE BY CHILDREN OR MENTALLY CHALLENGED PERSONS SHOULD BE ALWAYS SUPERVISED TO ENSURE THEIR SAFETY. THE HEARING INSTRUMENT CONTAINS SMALL PARTS THAT COULD BE SWALLOWED BY CHILDREN. PLEASE BE MINDFUL NOT TO LEAVE CHILDREN UNSUPERVISED WITH THIS HEARING INSTRUMENT'. THE USER GUIDE ALSO INCLUDES A RECOMMENDATION TO IMMEDIATELY SEEK MEDICAL ATTENTION IF IT IS SWALLOWED. ADDITIONALLY, THE USER GUIDE STATES IF A HEARING AID IS BROKEN, DO NOT USE IT. CLINICAL EVALUATION ACCORDING TO 0378040 CLIN EVAL PLAN&RPT, HA&TSG: HEARING AID POWERING IS A PRECONDITION FOR THE HEARING AID TO FUNCTION. THE RISKS ASSOCIATED WITH POWERING AND BATTERIES ARE REDUCED AS FAR AS POSSIBLE AND THE BENEFIT OF A HEARING AID OUTWEIGHS THESE RISKS. DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION. THIS IS AN INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF: #(B)(4). PRELIMINARY INVESTIGATION CONCLUDED THAT BOTH UNITS HAD BEEN PASSED THROUGH THE TEST PRIOR TO SHIPMENT AND NO ABNORMALITY CAPTURED THROUGHOUT THE PROCESS. BOTH UNITS WERE MANUFACTURED ON (B)(6) 2021 VIA DHR WO21704318 (2 YEARS AGO). IT HAS BEEN FOUND THAT THE BATTERY DOOR IS WEEK AND NEEDS THOROUGH INVESTIGATION. THE DEVICE INVESTIGATION IS STILL TO BE FINALISED. CLINICAL ASSESSMENT CONCLUSION IT IS REPORTED THAT 'PATIENTS BATTERY DOORS WILL NOT STAY CLOSED'. THIS CONCERNS BTE (BEHIND THE EAR) DEVICES AND THEREFORE THE RISK OF FOREIGN BODY IN THE EAR IS NOT APPLICABLE. DUE TO THE MISSING PART, THE BATTERY DOOR FOR THE HEARING AID WILL NOT STAY CLOSED AND THE DEVICE WILL NOT FUNCTION. CLINICAL CONCLUSION OF THE CASE IS THERE WAS NO POTENTIAL PATIENT HARM. THE USER GUIDE INCLUDES A WARNING STATING - INSTRUMENT USAGE BY CHILDREN OR MENTALLY CHALLENGED PERSONS SHOULD BE ALWAYS SUPERVISED TO ENSURE THEIR SAFETY. THE HEARING INSTRUMENT CONTAINS SMALL PARTS THAT COULD BE SWALLOWED BY CHILDREN. PLEASE BE MINDFUL NOT TO LEAVE CHILDREN UNSUPERVISED WITH THIS HEARING INSTRUMENT'. THE USER GUIDE ALSO INCLUDES A RECOMMENDATION TO IMMEDIATELY SEEK MEDICAL ATTENTION IF IT IS SWALLOWED. ADDITIONALLY, THE USER GUIDE STATES IF A HEARING AID IS BROKEN, DO NOT USE IT. CLINICAL EVALUATION ACCORDING TO 0378040 CLIN EVAL PLAN&RPT,HA&TSG: HEARING AID POWERING IS A PRECONDITION FOR THE HEARING AID TO FUNCTION. THE RISKS ASSOCIATED WITH POWERING AND BATTERIES ARE REDUCED AS FAR AS POSSIBLE AND THE BENEFIT OF A HEARING AID OUTWEIGHS THESE RISKS. RISK ASSESSMENT: KNOWN RISK. MITIGATED. RISK DEEMED ACCEPTABLE. THIS IS A FOLLOW UP REPORT. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVSTIGATIONS ARE FINALIZED. THE CASE IS LATE AND A NC-02241 HAS BEEN FILED FOR THIS ERROR. (B)(6) 2023: FOLLOW UP: DEVICE INVESTIGATION REVEALED THAT THE ROOT CAUSE OF THIS CASE IS THAT THE BATTERY CLICK IS OUT OF SPECS. BY CHECKING THE DEVICES, IT IS NOT CLEAR IF THIS OUT OF SPEC HAPPENS BECAUSE OF PART MANUFACTURE OR BY MISUSE. CORRECTIONS: THE COMPONET CODE HAS BEEN CHANGED FROM BATTERY TO LOCKING MECHANISM. THIS IS A FINAL REPORT. THIS CASE IS CONSIDERED AS A SINGLE INCIDENT AND WILL BE INCLUDED IN REGULAR TRENDING. NO ACTIONS HAVE BEEN INITIATED BASED ON THIS INDIVIDUAL EVENT.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE PATIENTS BATTERY DOORS WILL NOT STAY CLOSED. THIS IS A FOLLOW UP REPORT.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE PATIENTS BATTERY DOORS WILL NOT STAY CLOSED. THIS IS AN INITIAL REPORT.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE PATIENTS BATTERY DOORS WILL NOT STAY CLOSED. NO FURTHER INFORMATION HAS BEEN REPORTED REGARDING THE EVENT. THIS IS A FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558807 GN RESOUND HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY. OSM GN HEARING A/S 20967277 05708296156856

    Patients

    Seq Age Sex Outcome Treatment
    1 Male