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

Model Number	21790300
Medical Device Problem Code	Overheating of Device (1437)
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
Manufacture ref: #sf 03129211 technical investigation of actual device conclusion: a returned apollo 5.3 c-1 charger shows signs of deformation and overheating inside the usb type c connector.A low ohmic connection had appeared between vbus and the grounded metal housing inside the cable connector.Contaminants or wear and tear of the cable or charger connector may have caused it.A short-circuit will emit heat when the cable is connected to the wall charger, causing up to the rated 5 w of the wall charger to be dissipated inside the connector.There are no signs of fire on the device's interior or exterior surface.Risk assessment: based on the information provided this appears to be a known risk which is covered by an existing capa.All resulting actions are contained within the capa which includes assessment of risks and associated updates.A dhr review have been completed.No deviation or changes were found during manufacturing of the device.Clinical evaluation: it has been reported that the user saw the charger lit up, after which it went dead.It is unclear if original accessories were used.There was no harm to the user, and no mention of property damage.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 final report.
Event or Problem Description
It has been reported that on (b)(6) 2023 (estimated date)- charger lit up, went dead, got hot and smelled like fire.It does not appear that original accessories have been used.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: 17278355
• Report Number: 3005650109-2023-00096
• Device Sequence Number: 5086320
• Product Code: OSM
• UDI-Device Identifier: 05708296214440
• UDI-Public: 05708296214440
• 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): 07/07/2023

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: 21790300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown