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

Model Number	21763000
Medical Device Problem Codes	Material Discolored (1170); Overheating of Device (1437); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).18-jan-2023: technical investigation concluded: a device history record review has been completed.No deviation or changes were found during manufacturing of the device investigation is still in progress; a final report will be submitted upon completion.
Event or Problem Description
18-jan-2023: it was reported the charger showed sign of heat and there was discoloration near charging port.Incident date was (b)(6) 2022.The user was not harmed.Original equipment was used.The replacement device was provided to the patient.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).18-jan-2023: technical investigation concluded: a device history record review has been completed.No deviation or changes were found during manufacturing of the device investigation is still in progress; a final report will be submitted upon completion.15-feb-2023: investigation is still in progress; a final report will be submitted upon completion.
Event or Problem Description
18-jan-2023: it was reported the charger showed sign of heat and there was discoloration near charging port.Incident date was (b)(6) 2022.The user was not harmed.Original equitment was used.The replacement device was provided to the patient.(b)(6) 2023: no further information expected.
Event or Problem Description
18-jan-2023: it was reported the charger showed sign of heat and there was discoloration near charging port.Incident date was 15-nov-2022.The user was not harmed.Original equitment was used.The replacement device was provided to the patient.15-feb-2023: no further information expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).18-jan-2023: technical investigation concluded: a device history record review has been completed.No deviation or changes were found during manufacturing of the device investigation is still in progress; a final report will be submitted upon completion.15-feb-2023: investigation is still in progress; a final report will be submitted upon completion.16-mar-2023: technical investigation concluded: a dhr review has been completed.No deviation or changes were found during manufacturing of the device.Device investigation concluded: the r&d investigation found that the returned device has severe white discoloration, both on the back and bottom lip.Pcb of the charger in perfect condition.No signs of overheating (no deformations, connector still in excellent condition) no signs point towards device failure, damage most likely done by external factor.The clinical investigation concluded: the clinical evaluation for the device family does evaluate the overheated chargers.This is identified in the risk analysis.The chargers have been tested according to applicable safety standards.These risks are reduced as far as possible and the probability of occurrence of these events is considered very low.Based on the device investigation this event is however more likely a result of user error.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 conclusion herein are sufficient.Risk register conclusion: the residual risk after the risk control measure(s) is acceptable.No new hazardous situations revealed and no need to update the risk register.Manufacturer's investigation are final.This is a final report.

• 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: karen frisk ; lautrupbjerg 7; ballerup 2750 ; DA 2750
• MDR Report Key: 16203129
• Report Number: 3005650109-2023-00007
• Device Sequence Number: 12169163
• Product Code: OSM
• UDI-Device Identifier: 05708296215836
• UDI-Public: 05708296215836
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2023

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: 21763000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 12/20/2022; 12/20/2022
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/16/2023; 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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: 65 YR
• Patient Sex: Female