MAUDE Adverse Event Report: GN HEARING A/S GN RESOUND; HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY

Model Number	21384500
Medical Device Problem Codes	Product Quality Problem (1506); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation is ongoing.A final report will be submitted upon completion of the investigation this is an initial report.
Event or Problem Description
It was reported that on (b)(6) 2024 the receiver of the hearing aid was broken and when it was replaced the hearing care professional checked that the hearing aid didn't charge (and user said it didn't work correctly).After being asked about how the receiver was broken, the hearing care professional thinks that is likely that it occurred when the hearing instrument went to be worn/unworn due to the wear.The object did not require removal and no harm to the user was reported.No further follow up is expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation is ongoing.A final report will be submitted upon completion of the investigation.This is an initial report.23-aug-2024: device history record review: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.Device inspection: verified on the picture, the bottom housing was detached from the receiver.Clinical assessment: clinical evaluation of the event: it was reported that on 03jun2024 the receiver was broken and the receiver is detached from the piece of plastic located in the contact between the receiver and the cables.And the hearing care professional (hcp) thinks that it is likely that it occurred when the hearing instrument went to be worn/unworn due to the wear.User is a first time user and has not experienced this issue before.The receiver did not require removal and no harm to the user was reported.Clinical evaluation according to clin eval plan&rpt,ha&tsg and clin eval plan&rpt,other acc: the clinical evaluation for the device family does evaluate receivers coming loose in the ear canal.This is identified in the risk analysis and mitigated through device design by ensuring a sufficient pull force (compliance with (b)(4)).The user guide states to contact the hcp if a foreign object or wax is located in the ear canal to reduce the potential risk of harm as far as possible.There are no new clinical aspects (e.G.Unforeseen use or clinical conditions) discovered from this event.Therefore, it is concluded that the current clinical evaluation and risk/benefit conclusions herein are sufficient.Risk assessment : risk reg 0457500 ttm03.Risk id acc-tm-d-us2-17.Risk is known, and risk controls are in place.Covered by capa0641.All resulting actions are contained within the capa which includes assessment of risks and associated updates.Manufacturer's investigation is final.This is a final report.
Event or Problem Description
It was reported that on 03jun2024 the receiver of the hearing aid was broken and when it was replaced the hearing care professional checked that the hearing aid didn't charge (and user said it didn't work correctly).After being asked about how the receiver was broken, the hearing care professional thinks that is likely that it occurred when the hearing instrument went to be worn/unworn due to the wear.The object did not require removal and no harm to the user was reported.No further follow up is expected.

• Brand Name: GN RESOUND
• Common Device Name: HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• Manufacturer Contact: akanksha roy ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 19826618
• Report Number: 3005650109-2024-00060
• Device Sequence Number: 18313840
• Product Code: OSM
• UDI-Device Identifier: 05708296219339
• UDI-Public: 05708296219339
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 21384500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female