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

Model Number	22345400
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
22may2023 it was reported that charger overheated "melted and black in some areas".Clinician was unable to confirm if proper charging cable was being used.No injuries to patient or property.This is a combined report.No further follow up is expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Technical investigation concluded: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.Trended case concluded: 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: it has been reported that the custom charger overheated, resulting in melting and black in some areas.No property damage reported.There was no harm to the user, and therefore no medical attention.It is uncertain if the cable used was original.Replacement of charger and inserts has been ordered.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.Manufacturer's investigation is final.This is a combined (initial and 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: 17162731
• Report Number: 3005650109-2023-00078
• Device Sequence Number: 14866493
• Product Code: OSM
• UDI-Device Identifier: 05708296251261
• UDI-Public: 05708296251261
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 06/20/2023

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: 22345400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown