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

Model Number	21625000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Technical investigation concluded: device history record review has been completed.No deviation or changes were found during manufacturing of the device.Trended case device investigation 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.Clinical assessment concluded: based on the result from r&d investigation of trended case, clinical conclusion on the case is that there is a potential risk of heat dissipation based on the findings.Clinical evaluation is as follows; a damaged power supply or a power supply of very poor quality could lead to burn injuries and in rare conditions there is a small risk that a wrong charging or discharging or a battery thermal runway can lead to high temperatures or fire accidents.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.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 assessment is pending, to be submitted with final report.
Event or Problem Description
18-jan-2023: it was reported that on unknown date (b)(6) 2022 is a best estimate) charger burned in the back where it plugs in.Follow up information received on 30-dec-2022.The charger was plugged in and melted the cord.The hearing aids where in the charger when the event took place.The patient confirms that the hearing aids work fine.Original equipment was used.No harm to the patient or property reported.Hearing care provider advised the patient not to use the damaged charger and has sent a replacement device.No further follow up information expected.
Event or Problem Description
18-jan-2023: it was reported that on unknown date (december 2022 is a best estimate) charger burned in the back where it plugs in.Follow up information received on 30-dec-2022.The charger was plugged in and melted the cord.The hearing aids where in the charger when the event took place.The patient confirms that the hearing aids work fine.Original equipment was used.No harm to the patient or property reported.Hearing care provider advised the patient not to use the damaged charger and has sent a replacement device.No further follow up information expected.
Additional Manufacturer Narrative
Manufacturer's ref#(b)(4).Technical investigation concluded: device history record review has been completed.No deviation or changes were found during manufacturing of the device.Trended case device investigation 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.Clinical assessment concluded: based on the result from r&d investigation of trended case, clinical conclusion on the case is that there is a potential risk of heat dissipation based on the findings.Clinical evaluation is as follows; a damaged power supply or a power supply of very poor quality could lead to burn injuries and in rare conditions there is a small risk that a wrong charging or discharging or a battery thermal runway can lead to high temperatures or fire accidents.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.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 assessment is peding, to be submitted with final report.31-jan-2023 d9, date returned to the manufacturer added.Risk assessment conlusion: the residual risk after the risk control measure(s) is acceptable.No new hazardous situations revealed and no need to update the risk register.Manufacturer's nvestigation is final.This is final report.

• 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: karen frisk ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 16201365
• Report Number: 3005650109-2023-00008
• Device Sequence Number: 20240659
• Product Code: OSM
• UDI-Device Identifier: 05708296200061
• UDI-Public: 05708296200061
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 01/31/2023

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: 21625000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2020
• 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: Unknown