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

Model Number	21385500
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Technical investigation concluded: dhr review has been completed.No deviation or changes were found during manufacturing of the device.Trended case conclusion: adhesive failure mode is observed on failed devices.Adhesive to adherent interfaces detached from each other.Adhesive failure modes occur due to several factors such as inappropriate adhesive selection, pure surface preparation, and exposure to environmental factors.Assembly lines do not overlap totally but leave open gaps, creating pockets for ingress and retention of adhesion degrading media.Used adhesive technical sheet suggests avoiding adhesive usage in chlorinated environments - we have body contacts.The clinical investigation concluded: it was reported that a sf3 receiver came apart in hands while hearing care provider (hcp) was cleaning the hearing aids.Clinical conclusion is that the detached receiver has not caused harm to the user or hcp.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 iec 60601-2-66).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 register reference: risk related to mechanical damage are generally known mitigated and communicated to the user.For this risk, refer to capa.All resulting actions are contained within the capa which includes assessment of risks and associated updates.Manufacturers investigation is final.This is a combined (initial and final) report.
Event or Problem Description
Patient came in the office of the hearing care professional for his 4 month service appointment on august 29th.While cleaning the hearing aid and removing the left dome, the top part of the receiver fell off.It never came off in the patient's ear.No harm or injury reported.

• Brand Name: GN HEARING
• 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: 20319117
• Report Number: 3005650109-2024-00076
• Device Sequence Number: 20779121
• Product Code: OSM
• UDI-Device Identifier: 05708296219438
• UDI-Public: 05708296219438
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 09/26/2024

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: 21385500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2023
• 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 Sex: Male