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

Model Number	21900500
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Date of incident is estimated date (b)(6) 2023.It has been reported that- a patient said that the charger started smoking and melted.No other information is available at this point.This is an initial report.
Additional Manufacturer Narrative
Manufacturer ref: (b)(4).Trended device conclusion: the usb-c connector has broken down mechanical.It is a known problem with usb connectors, that in rare cases wear or dirt/moist can create a low ohmic path from vbus to gnd, that potential can cause a heating inside of the connector.Manufacturer investigation is pending.This is an initial report.A final report will be submitted on completion of investigations.
Event or Problem Description
Date of incident is estimated date (b)(6) 2023.It has been reported that- a patient said that the charger started smoking and melted.No further information is available.This is a final report.
Additional Manufacturer Narrative
Manufacturer ref: #(b)(4).Trended device conclusion: the usb-c connector has broken down mechanical.It is a known problem with usb connectors, that in rare cases wear or dirt/moist can create a low ohmic path from vbus to gnd, that potential can cause a heating inside of the connector.Technical conclusion of the actual device revealed no signs of fire on the device, both when examining the exterior and interior surfaces.A dhr review have been completed.No deviation or changes were found during manufacturing of the device.Based on the information provided this appears to be a known risk which is covered by existing capa 616.All resulting actions are contained within the capa which includes assessment of risks and associated updates.Clinical evaluation: it has been reported that the charger started smoking and melted.There was no harm to the user, and no reported property damage.It is concluded that the current clinical evaluation and risk/benefit conclusion herein are sufficient.This is a final report.No further information is 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 ; lauptrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 17265374
• Report Number: 3005650109-2023-00095
• Device Sequence Number: 8061980
• Product Code: OSM
• UDI-Device Identifier: 05708296217113
• UDI-Public: 05708296217113
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 08/03/2023

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: 21900500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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