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

Model Number	21790300
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's reference: (b)(4).Investigation is in progress.A final report will be submitted upon completion.
Event or Problem Description
On an unknown date in (b)(6) 2023 (best estimate), a patient reported to their hcp that the charger is overheating - uncomfortably hot to the touch.Hcp advised to unplug the charger.A replacement charger was sent.No allegation of harm or damage to person or property.
Event or Problem Description
On an unknown date in february 2023 (best estimate), a patient reported to their hcp that the charger is overheating - uncomfortably hot to the touch.Hcp advised to unplug the charger.A replacement charger was sent.No allegation of harm or damage to person or property.(b)(6) 2023 original equipment was used.
Additional Manufacturer Narrative
Manufacturer's reference: (b)(4) investigation is in progress.A final report will be submitted upon completion.(b)(6) 2023 technical investigation concluded: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.Trended case device investigation conclusion: the usb-c connector has broken down mechanical.It is a known problem with usb connectors, that in rare cases wear or dirt/moist can create a low ohmic path from vbus to gnd, that potential can cause a heating inside of the connector the device was returned and investigated: a returned apollo 5.3 c-1 charger shows signs of deformation and overheating inside the usb c connector.A low ohmic connection had appeared between vbus (pin b9) and the grounded metal plate inside the connector.The short-circuit will emit heat when the cable is connected to the wall charger, causing up to the rated 5 w of the wall charger to be dissipated inside the connector.Clinical assessment concluded: it was reported that the charger was overheating and uncomfortably hot to the touch.The charger overheated sitting on the nightstand.No patient harm or property damage reported.Original equipment was used.Based on the result from r&d investigation from trended case, clinical conclusion on the case is that there is a potential risk of heat dissipation based on the findings.A damaged power supply or a power supply of very poor quality could lead to burn injuries and in rare conditions there is a small risk that a wrong charging or discharging or a battery thermal runway can lead to high temperatures or fire accidents.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.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 risk assessment concluded: the residual risk after the risk control measure(s) is acceptable.No new hazardous situations revealed and no need to update the risk register.Manufacturer's investigation is final.This is a final report.

• 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: 16590710
• Report Number: 3005650109-2023-00037
• Device Sequence Number: 11998679
• Product Code: OSM
• UDI-Device Identifier: 05708296214440
• UDI-Public: 05708296214440
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 04/19/2023

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: 21790300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• 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: Male