MAUDE Adverse Event Report: GN HEARING A/S GN RESOUND; HEARING AID CHARGER

Model Number	21588900
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Investigation is still in progress, a final report will be submitted upon completion.
Event or Problem Description
On (b)(6) 2022 it was reported 'charger is getting hot and melted at the charger port'.The customer reported 'my charger shorted out and melted the other day' there is no harm to the customer reported.Follow up information will be submitted once completed.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Investigation is still in progress, a final report will be submitted upon completion.Follow up: the device has been replaced.Technical investigation concluded: no deviation or changes were found during manufacturing of the device.Trended case investigation: 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.Micro usb is a very well known and used standard but can mechanically break down.The clinical investigation concluded: 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, it is recommended that user guides are updated to recommend unplugging devices that are damaged and then waiting to touch until the device is no longer warm/a couple of hours.Risk register will be updated to include a new warning.Based on the available information, the case is still considered reportable as the event / incident did lead to, or might have led to, death or a serious injury if it recurred.This is a final report.No further follow up is expected.
Event or Problem Description
On 18jul2022- it was reported 'charger is getting hot and melted at the charger port'.The customer reported 'my charger shorted out and melted the other day' there is no harm to the customer reported.(b)(6) 2022: follow up information: the charger was plugged in the night and damage was noted in the morning.Original accessories have been used.The charger has been replaced.No further follow up is expected.

• Brand Name: GN RESOUND
• Common Device Name: HEARING AID CHARGER
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• Manufacturer Contact: karen bryde frisk ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 15238707
• Report Number: 3005650109-2022-00018
• Device Sequence Number: 20406575
• Product Code: OSM
• UDI-Device Identifier: 05708296200375
• UDI-Public: 05708296200375
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

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: 21588900
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2020
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown