MAUDE Adverse Event Report: GN HEARING A/S GN RESOUND; 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	04/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).A dhr review have been completed.No deviation or changes were found during manufacturing of the device.Trended analysis conclusion: the malfunction in the device is purely a breakdown of the micro usb connector.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.This is an initial report.Investigation is still in progress; a final report will be submitted upon completion.
Event or Problem Description
Estimated date of incident (b)(6) 2023.It is reported that the charger melted at usb port.There was no harm to the user.No property damage reported.Awareness date: (b)(6) 2023.Further follow up is expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).A dhr review have been completed.No deviation or changes were found during manufacturing of the device.Trended analysis conclusion: the malfunction in the device is purely a breakdown of the micro usb connector.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.This is an initial report.Investigation is still in progress; a final report will be submitted upon completion.10aug2023.Clinical evaluation of the event: it has been reported that the charger melted at the usb connection.User had unplugged it when they saw it smoking.There was no harm to the user, and no reported property damage.It is unknown if 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.Risk register reference: based on the information provided this appears to be a known risk which is covered by an existing capa0647.All resulting actions are contained within the capa which includes assessment of risks and associated updates.Manufacturers investigation is final,.This is a final report.
Event or Problem Description
Estimated date of incident 01-apr-2023.It is reported that the charger melted at usb port.There was no harm to the user.No property damage reported.Awareness date: 14jun2023.Further follow up is expected.10aug2023 no further follow up received.No further follow up is expected.

• 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: akanksha roy ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 17314724
• Report Number: 3005650109-2023-00103
• Device Sequence Number: 3995860
• Product Code: OSM
• UDI-Device Identifier: 05708296200139
• UDI-Public: 05708296200139
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 08/10/2023

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: 06/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/26/2021
• 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