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 reference: (b)(4).Investigation is ongoing and a final report shall be submitted upon completion.This is an initial report.
Event or Problem Description
23-jun-2023: on an uknown date ( best estimate) charger found with melted usb port.User noticed he saw smoke and red in the corner and the charger was very hot.But no actual flames.User not sure when it happened, but it was within the last 3 months.No harm to user or property reported.No medical attention sought and no medication prescribed.Original equipment used.
Additional Manufacturer Narrative
Manufacturer's reference: (b)(4) investigation is ongoing and a final report shall be submitted upon completion.This is an initial report.(b)(4) 2023: investigation is still ongoing and a final report will be submitted upon completion.
Event or Problem Description
(b)(6)2023: on an uknown date ( best estimate) charger found with melted usb port.User noticed he saw smoke and red in the corner and the charger was very hot.But no actual flames.User not sure when it happened, but it was within the last 3 months.No harm to user or property reported.No medical attention sought and no medication prescribed.Original equipment used.
Event or Problem Description
(b)(6)-2023: on an uknown date ( best estimate) charger found with melted usb port.User noticed he saw smoke and red in the corner and the charger was very hot.But no actual flames.User not sure when it happened, but it was within the last 3 months.No harm to user or property reported.No medical attention sought and no medication prescribed.Original equipment used.
Additional Manufacturer Narrative
Manufacturer's reference: (b)(4) investigation is ongoing and a final report shall be submitted upon completion.This is an initial report.(b)(6) 2023: investigation is still ongoing and 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 investigation concluded: the connector breaks, probably because the user has (not intentionally) misused it, while inserting the cable.If the cable has been slightly out of specification that could have had a negative effect on this.This has caused a low ohmic connection in the cable connector - almost a short circuit - that will emit heat when the cable is inserted into the wall charger, causing up to the rated 5 w of the wall charger to be dissipated inside the connector.Micro usb is a very well known and used standard but can mechanically break down.Device investigation concluded: 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 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 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 investigation concluded: it is reported that the user's charger melted at the usb port and cable, and that now one hearing aid is not working.User saw smoke and red in the corner, and charger got very hot.Accessories used were original.There was no harm to the user and therefore no medical attention, no reports of any property damage.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 assessment concluded: no new hazardous situations revealed and no need to update the risk register.Based on the information provided this appears to be a known risk which is covered by an existing capa.All resulting actions are contained within the capa which includes assessment of risks and associated updates.This is a final report.Manufacturer's investigation is final.

• 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: 17189508
• Report Number: 3005650109-2023-00081
• Device Sequence Number: 5807032
• Product Code: OSM
• UDI-Device Identifier: 05708296147113
• UDI-Public: 05708296147113
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 08/15/2023

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
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 05/24/2023; 05/24/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 07/21/2023; 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2019
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male