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	07/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2022: manufacturer's ref# (b)(4).Investigation is still in progress, a final report will be submitted upon completion.
Event or Problem Description
On (b)(6) 2022: charger port melted the cord.
Event or Problem Description
26aug2022: charger port melted the cord.Follow up: 20sep2022: charger was plugged into wall and the cord started to melt and smell.It was reported no harm of the user.The hearing aid and accessory was purchased on 16-jun-2021.
Additional Manufacturer Narrative
26aug2022: manufacturer's ref# (b)(6).Investigation is still in progress, a final report will be submitted upon completion.20-sep-2022: preliminary investigation: no deviation or changes were found during manufacturing of the device.Investigation is still in progress, a final report will be submitted upon completion.Corrections from initial report: e1: updated the initial reporter.
Additional Manufacturer Narrative
On 26aug2022: manufacturer's ref# (b)(4).Investigation is still in progress, a final report will be submitted upon completion.On 20-sep-2022: preliminary investigation: no deviation or changes were found during manufacturing of the device.Investigation is still in progress, a final report will be submitted upon completion.Corrections from initial report: e1: updated the initial reporter on 19-oct-2022: investigation is still in progress, a final report will be submitted upon completion.On 18-nov-2022: corrected data in g2.Investigation of trended case has been performed: 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 and risk assessment are still in progress, a final report will be submitted upon completion.On 12-dec-2022: the clinical investigation concluded: a damaged power supply or a power supply of very poor quality could potentially lead to burn injuries and in rare conditions there is a small risk that a wrong charging or discharging or a battery thermal runaway can lead to high temperatures or fire accidents.The chargers have been safety tested according to applicable standards.These risks are considered low.There are no new clinical aspects (e.G.Unforeseen use or clinical conditions) discovered from this event.However, to prevent any others being harmed going forward recommend user guides updated to recommend unplugging devices that are damaged and then waiting to touch until the device is no longer warm/a couple of hours and also make changes to the connector so that it is more robust /less likely to fail when it is accidently misused.Risk register 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.Manufacturer's investigation is final.This is a final report.
Event or Problem Description
On 26aug2022: charger port melted the cord.Follow up: on 20sep2022: charger was plugged into wall and the cord started to melt and smell.It was reported no harm of the user.The hearing aid and accessory was purchased on 16-jun-2021.On 19-oct-2022: the incident happened on 18-jul-2022.A replacement device was provided.On 12-dec-2022: no further follow up information is expected.
Event or Problem Description
26aug2022: charger port melted the cord.Follow up: 20sep2022: charger was plugged into wall and the cord started to melt and smell.It was reported no harm of the user.The hearing aid and accessory was purchased on 16-jun-2021.19-oct-2022: the incident happened on (b)(6) 2022.A replacement device was provided.
Additional Manufacturer Narrative
26aug2022: manufacturer's ref# (b)(6).Investigation is still in progress, a final report will be submitted upon completion.20-sep-2022: preliminary investigation: no deviation or changes were found during manufacturing of the device.Investigation is still in progress, a final report will be submitted upon completion.Corrections from initial report: e1: updated the initial reporter 19-oct-2022: investigation is still in progress, a final report will be submitted upon completion.18-nov-2022: corrected data in g2.Investigation of trended case has been performed: 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 and risk assessment are still in progress, a final report will be submitted upon completion.
Additional Manufacturer Narrative
26aug2022: manufacturer's ref# (b)(4).Investigation is still in progress, a final report will be submitted upon completion.20-sep-2022: preliminary investigation: no deviation or changes were found during manufacturing of the device.Investigation is still in progress, a final report will be submitted upon completion.Corrections from initial report: e1: updated the initial reporter 19-oct-2022: additional information in: - a3 - b3 - h2 updated information in: - g2 - g6 - h3 investigation is still in progress, a final report will be submitted upon completion.
Event or Problem Description
26aug2022: charger port melted the cord.Follow up: 20sep2022: charger was plugged into wall and the cord started to melt and smell.It was reported no harm of the user.The hearing aid and accessory was purchased on 16-jun-2021.19-oct-2022: the incident happened on (b)(6) 2022.A replacement device was provided.

• 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: karen frisk ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 15299780
• Report Number: 3005650109-2022-00025
• Device Sequence Number: 16745928
• Product Code: OSM
• UDI-Device Identifier: 05708296215836
• UDI-Public: 05708296215836
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/12/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 07/27/2022; 07/27/2022; 07/27/2022; 07/27/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 09/21/2022; 10/20/2022; 11/18/2022; 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/29/2020
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female