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	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023.Estimated date of incident (b)(6) 2023.On 08jun2023 it was reported: charger battery caught fire at connecting port.No harm to people or property.Further follow up is expected.
Additional Manufacturer Narrative
Manufacturer's ref: (b)(4).(b)(6)2023.Device investigation results: a returned apollo 5 c-1 charger shows signs of deformation and overheating inside the micro usb connector.A low ohmic connection had appeared between vbus and the grounded metal housing inside the cable connector.The vbus pin of the charger was protruding, and the tongue had a bend downwards, enabling the formation of a short-circuit.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.There are no signs of fire on the device's interior or exterior surface.Device history record review, clinical assessment and risk register conclusion pending, will be submitted on completion.This is an initial report.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Actual device investigation results: a returned apollo 5 c-1 charger shows signs of deformation and overheating inside the micro usb connector.A low ohmic connection had appeared between vbus and the grounded metal housing inside the cable connector.-the vbus pin of the charger was protruding, and the tongue had a bend downwards, enabling the formation of a short-circuit.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.There are no signs of fire on the device's interior or exterior surface.Clinical evaluation: it was reported that the charger battery caught fire at the connecting port.Device investigation showed a melted port, but no signs of fire.There was no mention of harm to user, nor their property.No mention of whether the accessories used were original.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 and risk/benefit conclusion herein are sufficient.Risk register conclusion 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.Manufacturer's investigation is final.This is a combined (initial and final) report (b)(6) 23: this case is late due to human error in its execution and submission.Manufacturer has identified and corrected through (b)(4).
Event or Problem Description
Estimated date of incident (b)(6) 2023.(b)(6) 2023 it was reported: charger battery caught fire at connecting port.No harm to people or property was reported.No further information is expected.

• 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: 17278199
• Report Number: 3005650109-2023-00091
• Device Sequence Number: 5173423
• Product Code: OSM
• UDI-Device Identifier: 05708296147137
• UDI-Public: 05708296147137
• 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,Followup
• Report Date (Section B): 08/07/2023

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
• Date Returned to Manufacturer: 06/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2018
• 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: Unknown