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

Model Number	20896300
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported- charger got so hot it melted at the charging port.She is not sure if the cable and wall adapter are ours.She will send in with complaint case # - it is out of warranty.The audiologist did not know if the ha inside the charger.The exact date of incident is unknown.This is a combined (initial and final) report.No further follow up is expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).The dhr review have been completed.No deviation or changes were found during manufacturing of the device.Technical investigation from parent case: the charger has been returned, because the micro usb interface has broken down, causing the device to become hot.Micro usb is a very well known and used standard but can mechanically break down.Clinical conclusion on the case is that, even though unpleasant, it is evaluated unlikely that the device in failure mode would cause harm, if the event was to reoccur, because of the unlikely event of contacting the difficult to touch location.Risk analysis is included, the residual risk after the risk control measure(s) is acceptable.Risk will update to include warning/caution to the users.Based on the available information, the malfunction may lead to, or might led to, death or a serious injury if it were to recur or the event / incident did lead to, or might have led to, death or a serious injury and indicates need for reporting.This is a combined report (initial and final).No further information 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: karen frisk ; lautrupbjerg 7; ballerup 2750 ; DA 2750
• MDR Report Key: 15578409
• Report Number: 3005650109-2022-00055
• Device Sequence Number: 7359706
• Product Code: OSM
• UDI-Device Identifier: 05708296156160
• UDI-Public: 05708296156160
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2022

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: 20896300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2019
• 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 Sex: Female