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

Model Number	22232804
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturers's ref# (b)(4): 06-dec-2022: technical investigation concluded: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.No investigation performed on actual device.Trended case investigation results: the returned apollo 5.3 charger is returned because the usb-c connector is broken down.The returned device has signs of heating around the usb-c connector, also the cable shows signs of heating.The charger is fully functional except of the connector.It can charge two hearing aids.The internal battery is working.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 clinical investigation concluded: results from previous internal investigation showed that the charger works fine when charging from charger's internal battery, meaning that the malfunction is purely a breakdown of the usb-c connector.This case also reported that the location of melting is where the cords plug.This is also supported by the picture provided.The connector is broken, suggesting that user has (not intentionally) misused it while inserting the cable.Based on results from previous evaluations, clinical conclusion on this case is that there is a potential risk of heat dissipation based on the finds.Clinical evaluation according to 0378080 clin eval plan&rpt,wl acc: a damaged power supply or a power supply of very poor quality could potentially lead to burn injuries and in rare conditions there is a small risk that a wrong charging or discharging or a battery thermal runaway can lead to high temperatures or fire accidents.The chargers have been safety tested according to applicable 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 conclusions herein are sufficient.Risk register reference: the residual risk after the risk control measure(s) is acceptable.No new hazardous situations revealed and no need to update the risk register.Based on the information the case is still considered reportable as the event / incident did lead to, or might led to, death or a serious injury.
Event or Problem Description
06-dec-2022: on unknown date (best estimate (b)(6) 2022) charger caught fire.Charger melted on the side where the cord plugs into the charger itself.This was during the charging of the hearing aid.No harm reported and no visit to the doctor.Rechargeable batteries were used.The original accessories/equipment was used.The hearing aids were replaced.

• Brand Name: GN HEARING
• Common Device Name: HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION
• 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: 15929944
• Report Number: 3005650109-2022-00076
• Device Sequence Number: 12403043
• Product Code: OSM
• UDI-Device Identifier: 05708296237821
• UDI-Public: 05708296237821
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2022

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: 22232804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown