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

Model Number	22176574
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	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref: (b)(4).Dhr: no abnormality and process change carried out.Investigation is still in progress; a final report will be submitted upon completion.
Event or Problem Description
It was reported that the end part of a receiver broke off in patient's ear and had to go to emergency department to have it removed.Follow up information is expected.
Event or Problem Description
It was reported that the end part of a receiver broke off in patient's ear and had to go to emergency department to have it removed.Follow up information is expected.On 14mar2024 it has been reported that the patient took the hearing aid off at the end of the day and saw that a part had come off.Clinician unsure if patient went straight to emergency department to have it removed or not.The part was removed at the emergency department.It is reported that the event did not cause physical harm to the patient, but made patient feel quite worried.Hearing care profesional provided a replacement.No further follow up information expected.
Additional Manufacturer Narrative
Manufacturer's ref: (b)(4).Dhr: no abnormality and process change carried out.Investigation is still in progress; a final report will be submitted upon completion.On 14mar2024, manufacturer's investigation conlusion: technical investigation concluded: device history records review found no abnormality and process change carried out.The clinical investigation concluded: clinical conclusion is that the detached receiver has not caused harm to the patient.Clinical evaluation according to clinical evaluation plan: 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: the residual risk after the risk control measure(s) is acceptable.No new hazardous situations revealed and no need to update the risk register trended case device investigation concluded: root cause were identified as per below: 1.Inadequate pfmea assessment on insufficient glue application.2.No mechanism to specify and control the glue application amount since this process is human driven with inconsistency.3.The exact bonding evaluation method is divert.The bonding shall be conducted between housing and receiver contact point.Not on front housing tip and receiver cable instead.Capa is closed.Manufacturer's investigation is final.This is a final report.

• 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: 18710226
• Report Number: 3005650109-2024-00013
• Device Sequence Number: 7187379
• Product Code: OSM
• UDI-Device Identifier: 05708296250899
• UDI-Public: 05708296250899
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/15/2024

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: 22176574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• 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: 64 YR
• Patient Sex: Female