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

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	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref # (b)(4): pending further investigation results.A final report will be submitted once investigations are complete.
Event or Problem Description
On 07-dec-2022: on unknown date (best estimate: (b)(6) 2022) charging unit melted in the back.The charger had burn marks and the plastic was melted.No harm was done to the patient and no visit to a doctor.Awaiting further information.
Additional Manufacturer Narrative
Manufacturer's ref # (b)(4): on 23-dec-2022: technical investigation concluded: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.No investigation done on the actual device.Trended case investigation results: the returned apollo 5.3 charger is returned because the usb-c connector is broken down.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 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.The clinical investigation concluded: clinical conclusion on the case is that, even though unpleasant, risk of high temperature and burn are mitigated by extensive safety testing according to standards according to master risk list.It is evaluated unlikely that the device in failure mode would cause harm, if the event was to reoccur, because of the unlikely event of contacting the difficult to touch location.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 investigations are complete.This report is final.On 07-dec-2022: pending further investigation results.A final report will be submitted once investigations are complete.
Event or Problem Description
On 23-dec-2022: several attempts to get more information.No information received.On 07-dec-2022: on unknown date (best estimate: 01-nov-2022) charging unit melted in the back.The charger had burn marks and the plastic was melted.No harm was done to the patient and no visit to a doctor.Awaiting further information.

• Brand Name: GN RESOUND
• Common Device Name: HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION
• 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: 15938340
• Report Number: 3005650109-2022-00078
• Device Sequence Number: 6219654
• Product Code: OSM
• UDI-Device Identifier: 05708296200061
• UDI-Public: 05708296200061
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/03/2023

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
• Date Returned to Manufacturer: 11/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2020
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown