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	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
In (b)(6) 2023 (best estimate), patient reported that she woke up to her charger smoking.Charger was plugged and was smoking.Original equipment was used.There were no reports of patient harm or injury, and no medical intervention was required.No further information is expected.
Additional Manufacturer Narrative
Manufacturer's reference: (b)(4).Technical investigation concluded: device history record review have been completed.No deviation or changes were found during manufacturing of the device trended case device investigation conclusion: 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 concluded: the case involves a charger with a melted/burnt charger port.No information received on the actions leading to this event.No patient harm or property damage reported.It is unknown if the original equipment was used.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 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: the residual risk after the risk control measure(s) is acceptable.No new hazardous situations identified and no requirement to update the risk register.Manufacturer's investigation is final.This is a combined initial and 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: 16520796
• Report Number: 3005650109-2023-00028
• Device Sequence Number: 12376588
• Product Code: OSM
• UDI-Device Identifier: 05708296200139
• UDI-Public: 05708296200139
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/09/2023

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: 02/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Female