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	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hearing aid charger port burned.No harm to the patient reported and no contact with authorized medical practitioner.The malfunction was actually discovered in the office of the hear care professional.Their belief is that it was a faulty outlet at the patient's office.Device was investigated at the hcp office, and has been replaced.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device the clinical investigation concluded: based on these results from previous evaluations, clinical conclusion on this case is that there is a potential risk of heat dissipation based on the findings.No harm was reported.This risk scenario is already identified within the clinical evaluation.Post market data on chargers show warm and melted chargers/parts of chargers.One of these cases were investigated and it was evaluated that the charger had been exposed to microwaves.Cases where parts of the chargers have melted have been investigated and shown to be related to the power supply.In all cases, harmful high temperatures have been limited to places that could not be touched.Further, a few cases of burning chargers have been reported.In rare cases a wrong charging or discharging or a battery thermal runaway can cause high temperatures that could potentially lead to fire.These risks are reduced as far as possible and the probability of occurrence of these events is considered very low.Therefore, the benefit of the charger is evaluated to outweigh the very low risk of fire.Risk assessment: risk register will be updated to include warning/caution to user.Hcp office did not return the device to manufacturer, they have investigated it and provided a replacement to the customer.R&d investigation conclusion is pending.To be reported when final.
Event or Problem Description
23-sep-2022 it was reported that the hearing aid charger port burned.No harm to the patient reported and no contact with authorized medical practitioner.The malfunction was actually discovered in the office of the hear care professional.Their belief is that it was a faulty outlet at the patient's office.Device was investigated at the hcp office, and has been replaced.18-oct-2022 no further information is expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).23-sep-2022 manufacturer's investigation: technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device the clinical investigation concluded: based on these results from previous evaluations, clinical conclusion on this case is that there is a potential risk of heat dissipation based on the findings.No harm was reported.This risk scenario is already identified within the clinical evaluation.Post market data on chargers show warm and melted chargers/parts of chargers.One of these cases were investigated and it was evaluated that the charger had been exposed to microwaves.Cases where parts of the chargers have melted have been investigated and shown to be related to the power supply.In all cases, harmful high temperatures have been limited to places that could not be touched.Further, a few cases of burning chargers have been reported.In rare cases a wrong charging or discharging or a battery thermal runaway can cause high temperatures that could potentially lead to fire.These risks are reduced as far as possible and the probability of occurrence of these events is considered very low.Therefore, the benefit of the charger is evaluated to outweigh the very low risk of fire.Risk assessment: risk register will be updated to include warning/caution to user.User facility did not return the device to manufacturer, they have investigated it and provided a replacement to the customer.R&d investigation conlusion is pending.To be reported when final.18 -oct-2022.Corrected data: -b4, -d8, -g2, -g6, -h7, -h8.R&d investigation conlusion is pending.To be reported when final.
Event or Problem Description
On 23-sep-2022: it was reported that the hearing aid charger port burned.No harm to the patient reported and no contact with authorized medical practitioner.The malfunction was actually discovered in the office of the hear care professional.Their belief is that it was a faulty outlet at the patient's office.Device was investigated at the hcp office, and has been replaced.On 18-oct-2022: no further information is expected.On 17-nov-2022: no further information is expected.This is a final report.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).On 23-sep-2022: manufacturer's investigation: technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device the clinical investigation concluded: based on these results from previous evaluations, clinical conclusion on this case is that there is a potential risk of heat dissipation based on the findings.No harm was reported.This risk scenario is already identified within the clinical evaluation.Post market data on chargers show warm and melted chargers/parts of chargers.One of these cases were investigated and it was evaluated that the charger had been exposed to microwaves.Cases where parts of the chargers have melted have been investigated and shown to be related to the power supply.In all cases, harmful high temperatures have been limited to places that could not be touched.Further, a few cases of burning chargers have been reported.In rare cases a wrong charging or discharging or a battery thermal runaway can cause high temperatures that could potentially lead to fire.These risks are reduced as far as possible and the probability of occurrence of these events is considered very low.Therefore, the benefit of the charger is evaluated to outweigh the very low risk of fire.Risk assessment: risk register will be updated to include warning/caution to user.User facility did not return the device to manufacturer, they have investigated it and provided a replacement to the customer.R&d investigation conlusion is pending.To be reported when final.R&d investigation conlusion is pending.To be reported when final.Added r&d investigation conlusion: the incident is connected to a trended case, with following investigation conlusion: "the returned device has signs of heating around the usb-c connector, also the cable shows signs of heating the charger is fully functional except of the connector.It can charge two hearing aids.The internal battery is working the usb-c connector has broken down mechanical.It is a known problem with usb-c 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" no further investigation expected.This is i 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: 15475177
• Report Number: 3005650109-2022-00040
• Device Sequence Number: 3050466
• Product Code: OSM
• UDI-Device Identifier: 05708296200061
• UDI-Public: 05708296200061
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Consumer,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2022

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: 21625000
• 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: 08/26/2022
• Supplement Date Received by Manufacturer: 08/26/2022; 08/26/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 10/21/2022; 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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: Unknown