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

Model Number	21763000
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
Event or Problem Description
Estimated date of incident (b)(6) 2023.(b)(6) 2023: although it was reported as a complaint- hearing aids won't hold charge, and charger intermittent.The images obtained of the device showed a melted charger port.Therefore this is case is assessed as reportable.It is unknown if original gn accessories were used at the time of incident.Further follow up is ongoing.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).(b)(6) 2023: device investigation results: a returned apollo 6 c-2 charger shows signs of deformation and overheating inside the usb c connector.A low ohmic connection had appeared between vbus and the grounded metal housing inside the cable connector.A cleaning agent was spilled on the charger, and not wipe completely clean before use the cleaning agent had entered the connector and acted as a contaminant.The contaminant formed a low ohmic connection, a short-circuit.The 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.This is an initial report.Further investigation is ongoing, a final report will be submitted on completion.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).(b)(6) 2023: device investigation results a returned apollo 6 c-2 charger shows signs of deformation and overheating inside the usb c connector.A low ohmic connection had appeared between vbus and the grounded metal housing inside the cable connector.A cleaning agent was spilled on the charger, and not wipe completely clean before use the cleaning agent had entered the connector and acted as a contaminant.The contaminant formed a low ohmic connection, a short-circuit.The 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.This is an initial report.Further investigation is ongoing, a final report will be submitted on completion.(b)(6)2o23 correction: based on device investigation, case has been re-assessed to non-reportable.Technical investigation concluded: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.The clinical investigation concluded: it has been reported that the charger wont hold charge, pictures show the charger is melted at cable port.Original accessories were used.There was no harm to the user, and no reports 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.Risk register conclusion reference: the residual risk after the risk control measure(s) is acceptable.No new hazardous situations revealed and no need to update the risk register.This is a final report.No further follow up is expected.
Event or Problem Description
Estimated date of incident (b)(6) 2023 (b)(6): although it was reported as a complaint- hearing aids won't hold charge, and charger intermittent.The images obtained of the device showed a melted charger port.Therefore this is case is assessed as reportable.It is unknown if original gn accessories were used at the time of incident.Further follow up is ongoing.(b)(6) follow up received (b)(6) 2023: original accessories were used at time of incident warranty expiration (b)(6) 2024.No further follow up expected.

• Brand Name: GN HEARING
• 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: 17331809
• Report Number: 3005650109-2023-00106
• Device Sequence Number: 6477517
• Product Code: OSM
• UDI-Device Identifier: 05708296215836
• UDI-Public: 05708296215836
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/15/2023

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: 21763000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2023
• Supplement Date Received by Manufacturer: 06/18/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2020
• 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