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

Model Number	20472100
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Investigation is still in progress; a final report will be submitted upon completion.
Event or Problem Description
On (b)(6) 2023, patient found charger burned at the charger usb slot and cable at home.No reports of patient harm or injury and no medical intervention was required.No damage to properties is reported.Unknown whether original equipment was used.Device has been requested back for further investigation.
Event or Problem Description
On (b)(6) 2023, patient found charger burned at the charger usb slot and cable at home.No reports of patient harm or injury and no medical intervention was required.No damage to properties is reported.Unknown whether original equipment was used.Device has been requested back for further investigation.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Investigation is still in progress; a final report will be submitted upon completion.28 april 2023: technical investigation concluded: device investigation concluded: the device in question, an apollo 5.1 c-1 charger showed 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 micro usb connector in the apollo 5.1 has mechanical limitations, if it is subjected to 'rough' handling by the user.The mechanical support (charger plastic housing) cannot mitigate the deformation of the connector.When that happens, it is open for wrong insertions of the connector.The pins of the female usb connector appears to bend downwards, which can create a non-ideal connection when the cable connector is inserted.A dhr review have been completed.No deviation or changes were found during manufacturing of the device.Clinical assessment concluded: clinical evaluation of the event: the case involves a micro charger port and wire overheated.No information received on the actions leading to this event.No patient harm or property damage reported.It is unknown if the original equipment was used.Based on the result from r&d investigation of the actual device, clinical conclusion on the case is that there is a potential risk of heat dissipation based on the findings.A low ohmic connection had appeared between vbus and the grounded metal housing inside the cable connector.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: 16644436
• Report Number: 3005650109-2023-00040
• Device Sequence Number: 5490784
• Product Code: OSM
• UDI-Device Identifier: 05708296147113
• UDI-Public: 05708296147113
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 04/28/2023

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: 20472100
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2019
• 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
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female