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

Model Number	20472100
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer reference: #(b)(4).Technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.No device is available for investigation.The clinical investigation concluded: it was reported that the charger was overheating- charger was smoking and leaking fluid.No patient harm or property damage reported.It was reported that it was unsure if it was the original power cord & adapter, but it was the original charger.Risk register reference: the residual risk after the risk control measure(s) is acceptable.This is covered in a capa.This is a combined (initial and final) report as no follow up is expected.
Event or Problem Description
It was reported: i am assuming incident happened on (b)(6) 2023.Her emailed stated that while charging her hearing aids, charger was smoking and leaking fluid.She removed hearing aids from charger (hearing aid working fine) and tossed charger, power cable and adapter in outside trash.She did not feel safe to have it in her home.No patient harm.Unsure if it was the original power cord & adapter.But it was the original charger.Bought in (b)(6) 2019.

• Brand Name: GN RESOUND
• Common Device Name: HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup 2750 ; DA 2750
• Manufacturer Contact: karen frsik ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 16775013
• Report Number: 3005650109-2023-00053
• Device Sequence Number: 6671285
• Product Code: OSM
• UDI-Device Identifier: 05708296147113
• UDI-Public: 05708296147113
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 04/20/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2019
• 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: Female