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

Model Number	20863700
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Skin Burning Sensation (4540)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the charger overheated and is totally melted with black residue coming out off it, charger is clearly melted at the point of connection to the power cord.Patient also burned their finger however it did not require medical attention.This is an initial report.
Additional Manufacturer Narrative
Manufacturer ref: (b)(4).Trended case analysis: the connector is broken, probably because the user has (not intentionally) misused it, while inserting the cable.If the cable has been slightly out of specification that could have had a negative effect on this.This has caused a low ohmic connection in the cable connector - almost a short circuit - that will emit heat when the cable is inserted into the wall charger, causing up to the rated 5 w of the wall charger to be dissipated inside the connector.Micro usb is a very well known and used standard but can mechanically break down.It has been reported that -charger is clearly melted at the point of connection to the power cord.Patient also burned their finger however it did not require medical attention'.Original accessories were used.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.This is an initial report.A final report will be submitted on completion of risk assessment and dhr findings.
Additional Manufacturer Narrative
Manufacturer ref: # (b)(4).Trended case analysis: the connector is broken, probably because the user has (not intentionally) misused it, while inserting the cable.If the cable has been slightly out of specification that could have had a negative effect on this.This has caused a low ohmic connection in the cable connector - almost a short circuit - that will emit heat when the cable is inserted into the wall charger, causing up to the rated 5 w of the wall charger to be dissipated inside the connector.Micro usb is a very well known and used standard but can mechanically break down.It has been reported that -charger is clearly melted at the point of connection to the power cord.Patient also burned their finger however it did not require medical attention'.Original accessories were used.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.This is an initial report.A final report will be submitted on completion of risk assessment and dhr findings.(b)(6) 2023.Correction: d9 - unticked "device received" and deleted "date received" - -device has not been receivet by manufacturer.A dhr review have been completed.No deviation or changes were found during manufacturing of the device manufacturers investigation is final,.This is a final report.
Event or Problem Description
It is reported that the charger overheated and is totally melted with black residue coming out off it, charger is clearly melted at the point of connection to the power cord.Patient also burned their finger however it did not require medical attention.This is an initial report.27jul2023 no further follow up has been received.

• Brand Name: GN HEARING A/S
• Common Device Name: HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
• Manufacturer (Section D): GN HEARING A/S; lauptrupbjerg 7; ballerup 2450 ; DA 2450
• Manufacturer Contact: karen frisk ; lautrupbjerg 7; ballerup, 2850 ; DA 2850
• MDR Report Key: 17238030
• Report Number: 3005650109-2023-00087
• Device Sequence Number: 7063986
• Product Code: OSM
• UDI-Device Identifier: 05708296147137
• UDI-Public: 05708296147137
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 07/27/2023

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: 20863700
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown