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

Model Number	21569800
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	04/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref: #sf (b)(4).A device history record review have been completed.No deviation or changes were found during manufacturing of the device.It has been reported that the patient burnt fingers which needed no medical attention.There is insufficient information at the moment to make an assessment.There is no evidence provided for the 'alleged burn' sustained.It is also unclear why the patient touched the charger when there was reported 'smoke and smell'.Risk assessment, clinical evaluation and device investigation is pending.This is an initial report.Investigation is still in progress; a final report will be submitted upon completion.
Event or Problem Description
It has been reported- charger started to smoke and smell -burned fingers -no medical attention.The malfunction happened on an unknown date ((b)(6) 2023 best estimate).Original equipment was used.There is no photo or medical confirmation of the alleged burn.Follow up is expected.
Additional Manufacturer Narrative
Manufacturer's ref: #(b)(4) a device history record review have been completed.No deviation or changes were found during manufacturing of the device.It has been reported that the patient burnt fingers which needed no medical attention.There is insufficient information at the moment to make an assessment.There is no evidence provided for the 'alleged burn' sustained.It is also unclear why the patient touched the charger when there was reported 'smoke and smell'.Risk assessment, clinical evaluation and device investigation is pending.This is an initial report.Investigation is still in progress; a final report will be submitted upon completion.08jun2023 changes in the report from initial report to final report: h3 device evaluated by manufacturer? changed from "device evaluation anticipated, but not yet begun (02)" to "device problem already known, no evaluation necessary (04)" h4 added manufacturing date of device based on the received photo it is identified plastic is melted at the charger where the cable plugs into the charger.No information received why the patient touched the charger when there was reported 'smoke and smell' - information received "the patient ddid touch the charger to disconnect it from the wall" 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.Clinical evaluatioon of the event: it has been reported that -the patient touched the charger and burned his fingers while trying to disconnect it from the wall despite the fact charger showed smoke and there was smell.No medical attention was needed.Original accessories were used.No property damage reported.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.This is a final report.
Event or Problem Description
It has been reported- charger started to smoke and smell -burned fingers -no medical attention.The malfunction happened on an unknown date (apr-2023 best estimate).Original equipment was used.There is no photo or medical confirmation of the alleged burn.Follow up is expected.08jun2023 the event occurred easter day (estimated 9apr2023) based on the received photo it is identified plastic is melted at the charger where the cable plugs into the charger.Device is bought 28jan2022 device is out of warranty.

• 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: 16912355
• Report Number: 3005650109-2023-00065
• Device Sequence Number: 20422173
• Product Code: OSM
• UDI-Device Identifier: 05708296200276
• UDI-Public: 05708296200276
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 21569800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2021
• 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: Male