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

Model Number	20863700
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).A dhr review have been completed.No deviation or changes were found during manufacturing of the device.This is an initial report.Manufacturer's investigation is ongoing and a final report will be submitted upon completion.
Event or Problem Description
On an unknown date in july (best estimate), patient tried to charge her hearing aids over the weekend, but it wasn't charging at all.She came into clinic on tuesday 4th of july so we can have a look.The tip of the cord was bent, so gave client a new cord.Client's son has come in on 7th of july reporting that he noticed that the charger was overheating on the bottom and that he could smell a burning smell, so he instantly took charger off of power.No report of harm to patient or property.Original equipment was used.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(6).A dhr review have been completed.No deviation or changes were found during manufacturing of the device.This is an initial report.Manufacturer's investigation is ongoing and a final report will be submitted upon completion.(b)(6) 2023 technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.Returned device investigation concluded: an apollo 5.1 c-1 charger has been returned due to it overheating.Investigation shows that there are no signs present of any overheating.Neither the plastic cover has been deformed/discoloured and the pcb has received any damage except the missing micro-usb b connector.Both the metal housing and receptacle had broken off, leaving only the solder pads on the pcb.Most of the components of the charger shows signs of wear and tear, but nothing that would easily allow this type of damage to occur on the charger.Clinical assessment concluded: it was reported that the charger overheated.The user had tried to charge her hearing aids over the weekend, but they were not charging.When she came into the clinic, the tip of the cord was bent, so she was given a new cord.3 days later, her son noticed that the charger was overheating on the bottom, and he could smell it.It was quickly taken off the power.There was no harm done to the user, and no mention of property damage.Original accessories were used.Clinical evaluation 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.In case of moisture, sweat or dirt in the connector, there can be high temperatures inside the connector due to power dissipation when connected to the charger plug.There can be melting of the plastic around the connector and is visible to the naked eye.It is highly unlikely that the user would touch in case there appears to be melting or high temperatures.In the unlikely event of the user touching this overheated device, it can lead to superficial or minor injury that would in most cases require no medical intervention.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 0378080 clin eval plan&rpt,wl acc 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.Based on this information, gnh have determined this case to be a non-reportable case.Device investigation has not confirmed areas of overheating.The case is considered not reportable as the event / incident did not lead to, or might led to, death or a serious injury.
Event or Problem Description
On an unknown date in july (best estimate), patient tried to charge her hearing aids over the weekend, but it wasn't charging at all.She came into clinic on (b)(6) so we can have a look.The tip of the cord was bent, so gave client a new cord.Client's son has come in on 7th of july reporting that he noticed that the charger was overheating on the bottom and that he could smell a burning smell, so he instantly took charger off of power.No report of harm to patient or property.Original equipment was used.

• Brand Name: GN HEARING
• 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: akanksha roy ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 17457442
• Report Number: 3005650109-2023-00117
• Device Sequence Number: 19478981
• Product Code: OSM
• UDI-Device Identifier: 05708296147137
• UDI-Public: 05708296147137
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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: 20863700
• 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: 07/07/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female