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

Model Number	22366472
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Estimated date of incident (b)(6) 2023 it was initially reported that the charger port caught on fire where the cord goes in has melted.It was confirmed that there was no evidence or noticing of actual flame in this incident.The charger was discovered by the patient's grandchildren who noticed an "electrical burning smell" when they entered the patient's home.The charger was found to be plugged in an had melted.The patient was sleeping during the incident while the hearing aids were in the charger.No actual flames were reported.No harm to the user or property has been reported.No device has been sent.Further follow up is not expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Technical conclusion: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.Actual device has been requested but not yet available.Trended case 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.Risk evaluation: all resulting actions are contained within the capa which includes assessment of risks and associated update.Clinical evaluation: it was reported that the charger port has melted.It was first reported that it caught fire, but it has been confirmed that there were no flames.The grandchildren of the user discovered an electrical burning smell.Hearing aids were in the charger, as the user was asleep.There was no harm to the user, and no reports of property damage.Original accessories were used.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.In case of moisture, sweat or dirt in the connector, there can be high temperatures inside the connector due to power dissipation when connected to the charger plug.There can be melting of the plastic around the connector and is visible to the naked eye.It is highly unlikely that the user would touch in case there appears to be melting or high temperatures.In the unlikely event of the user touching this overheated device, it can lead to superficial or minor injury that would in most cases require no medical intervention.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.This is a combined report as no further follow up 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 ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 17457355
• Report Number: 3005650109-2023-00115
• Device Sequence Number: 7152996
• Product Code: OSM
• UDI-Device Identifier: 05708296253098
• UDI-Public: 05708296253098
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 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: 22366472
• 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: 07/05/2023
• Initial Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• 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