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

Model Number	20472100
Medical Device Problem Codes	Overheating of Device (1437); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's reference: (b)(4).Investigation is ongoing, a final report will be submitted once investigation is complete.This is an initial report.
Event or Problem Description
On an unknown date (best guess is sometime in (b)(6) 2023), it was reported on (b)(6) 2023 that charger stopped working.It was reset and started working again but got very hot very fast.Images obtained of the device showed a melted charger port.There were no reports of patient harm or injury, and no medical intervention was required.No further information is expected.
Additional Manufacturer Narrative
Manufacturer's reference: (b)(4).Investigation is ongoing, a final report will be submitted once investigation is complete.This is an initial report.(b)(6) 2023.Technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device testing of actual device concluded: an apollo 5.1 c-1 was returned due to initially not charging and upon reset, got very hot.Visual inspection shows all components are in fine condition, no signs of damage anywhere on the charger.A test was performed to see if the overheating could be recreated.No overheating was observed for any of the components of the pcb of the charger was observed.Charger performed nominally, being able to charge the battery of the charger.Clinical evaluation: it has been reported that the charger stopped working, it was reset after which it started working again.However, it got hot very fast.Charger was then replaced.No mention of harm to the user, or their property.Risk assessment concluded: overheating issues are known about and their risk assessed and deemed to be acceptable.Based on the result of device investigation, where no product problem was found and no harm was reported by the user, this event is now determined to be non-reportable.
Event or Problem Description
On an unknown date (best guess is sometime in (b)(6) 2023), it was reported on (b)(6) 2023 that charger stopped working.It was reset and started working again but got very hot very fast.Images obtained of the device showed a melted charger port.There were no reports of patient harm or injury, and no medical intervention was required.No further information is expected.(b)(6) 2023.Images received were reviewed by device investigators and determined that the charger port was not melted, instead it showed signs of wear and tear.

• 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: karen frisk ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 17237483
• Report Number: 3005650109-2023-00086
• Device Sequence Number: 12537099
• Product Code: OSM
• UDI-Device Identifier: 05708296147113
• UDI-Public: 05708296147113
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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
• Report Date (Section B): 07/25/2023

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: 20472100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown