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

Model Number	21625700
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
Event or Problem Description
On (b)(6) 2022 it was reported that a patient plugged in the charger and started smelling like it was burning.Follow up information received on 21-dec-22 the patient had the charge plugged in to charge the aids and started smelling a burning smell, the charger was placed on the desk.The original charger was used, unsure if the cord was original.The device was bought on (b)(6) 2021 in(b)(6).No harm to the patient reported and no contact with authorised medical practitioner.Hearing care professional recommended to exchange for a different charger.The replacement(s) shipped to customer on 29-nov-2022.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Technical investigation concluded: a device history record review has been completed.No deviation or changes were found during manufacturing of the device.Trended case investigation conluded: 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 and risk register conlusion pending, to be submitted when available.
Event or Problem Description
On 01-dec-2022 it was reported that a patient on an unknown date plugged in the charger and started smelling like it was burning.Follow up information received on 21-dec-22: the patient had the charge plugged in to charge the aids and started smelling a burning smell, the charger was placed on the desk.The original charger was used, unsure if the cord was original.The device was bought on (b)(6) 2021 in (b)(6) us.No harm to the patient reported and no contact with authorised medical practitioner.Hearing care professional recommended to exchange for a different charger.The replacement(s) shipped to customer on (b)(6) 2022.26-jan-2023: no further information received, nor expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Technical investigation concluded: a device history record review has been completed.No deviation or changes were found during manufacturing of the device.Trended case investigation 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.Clinical assessment and risk register conlusion pending, to be submitted when available.26-jan-2023: clinical assessment conclusion: clinical conclusion on the case is that there is a potential risk of heat dissipation based on the findings.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 conclusion: 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.

• Brand Name: BELTONE
• 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: 16066606
• Report Number: 3005650109-2022-00088
• Device Sequence Number: 17818964
• Product Code: OSM
• UDI-Device Identifier: 05708296200139
• UDI-Public: 05708296200139
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/26/2023

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: 21625700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2021
• 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