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

Model Number	20623200
Medical Device Problem Codes	Temperature Problem (3022); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).This is a late report.Investigation is still in progress, a final report will be submitted upon completion.
Event or Problem Description
A complaint was filed on 07jul2022 about a hearing aid charger with evidence of melting at the ac adapter, not at the charger.Follow up information will be submitted once received.
Additional Manufacturer Narrative
Manufacturer's ref#: (b)(4).This is a late report.Additional information: 05sep2022 (b)(6): trended case device investigation conclusion: functional testing reveals that the charger works fine, when running on the internal battery.That means that the malfunction in the device is purly 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.Dhr conclusion.No deviation or changes were found during manufacturing.Risk register will be updated to include additional warning/caution to the users.Clinical evaluation of the event: from the previous investigations it is concluded that the high temperatures are generally limited to places difficult to touch, such as the back of the charger.Clinical conclusion on the case is that, even though unpleasant, it is evaluated unlikely that the device in failure mode would cause severe harm.However, to prevent any others being harmed going forward recommend user guides updated to recommend unplugging devices that are damaged and then waiting to touch until the device is no longer warm/a couple of hours.This is a final report.No further information is expected.
Event or Problem Description
A complaint was filed on 07jul2022 about a hearing aid charger with evidence of melting at the ac adapter, not at the charger.New charger being sent.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).This is a late report.Additional information: 05sep2022 aroy: trended case device investigation conclusion: functional testing reveals that the charger works fine, when running on the internal battery.That means that the malfunction in the device is purly 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.Dhr conclusion.No deviation or changes were found during manufacturing.Risk register will be updated to include additional warning/caution to the users.Clinical evaluation of the event: from the previous investigations it is concluded that the high temperatures are generally limited to places difficult to touch, such as the back of the charger.Clinical conclusion on the case is that, even though unpleasant, it is evaluated unlikely that the device in failure mode would cause severe harm.However, to prevent any others being harmed going forward recommend user guides updated to recommend unplugging devices that are damaged and then waiting to touch until the device is no longer warm/a couple of hours.26sep2022 follow up received: this is a final report.No further information is expected.Corrected data e1: initial reporter information corrected.
Event or Problem Description
A complaint was filed on 07jul2022 about a hearing aid charger with evidence of melting at the ac adapter, not at the charger.New charger being sent.Follow up received on 26 sep 2022: incident happened in mid april.Ha's needed charged so patient had to plug them in to charge, & then charger got hot and started melting while hearing aids were charging.The user is a 81 year old male.Date of purchase: 6/11/20, device covered in warranty.The age of the device is 2 years.The device has been returned on 3/31/22 and new charger received on 7/1/22.

• Brand Name: BELTONE IMAGINE
• 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: 15208085
• Report Number: 3005650109-2022-00017
• Device Sequence Number: 14652784
• Product Code: OSM
• UDI-Device Identifier: 05708296147120
• UDI-Public: 05708296147120
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2022

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: 20623200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/06/2022; 07/06/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/09/2022; 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2019
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male