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

Model Number	21385500
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	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: technical investigation concluded: preliminary investigation concluded that the units had been passed through the test prior to shipment with no abnormality before shipment.Clinical conclusion: clinical evaluation of the event: it was reported that the top housing separated from bottom housing on the receiver of the hearing aid while the hearing care professional wanted to swap out domes.No reports of parts getting stuck in the ear or requiring removal.No harm to the user reported.Clinical conclusion is that the detached receiver has not caused harm to the patient and no medical treatment was prescribed.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 assessment: refer to capa.All resulting actions are contained within the capa which includes assessment of risks and associated updates.Device investigation concluded: the device was not returned to the manufacturer so no actual device investigation could be conducted.Trended case device investigation findings: 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.Manufacturer's investigation is final.This is a combined (initial and final) report.
Event or Problem Description
Estimated date of incident (b)(6) 2024.It was reported that the top housing separated from the bottom housing on the receiver of the hearing aid while the hearing care professional wanted to swap out domes.No harm to the user was reported.No further follow up is available or 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: 19457876
• Report Number: 3005650109-2024-00052
• Device Sequence Number: 7907686
• Product Code: OSM
• UDI-Device Identifier: 05708296219438
• UDI-Public: 05708296219438
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/04/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 06/04/2024
• 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 Sex: Unknown