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

Model Number	22032400
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).On investigation of the photo of the charger, the port looks melted.The trend analysis shows 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 investigation is still ongoing, a final report will be submitted upon completion.
Event or Problem Description
It was reported in the complaint: jabra charger burned at charging port.Member stated this has been plugged into a device with other multiple ports for months and never had an issue until yesterday.No harm to people or property.Based on description it is where the cable plugs into the charger.
Event or Problem Description
It was reported in the complaint: jabra charger burnt at charging port.Member stated this has been plugged into a device with other multiple ports for months and never had an issue until yesterday.No harm to people or property.Based on description it is where the cable plugs into the charger.On (b)(6) 2023: no further follow up received.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).On investigation of the photo of the charger, the port looks melted.The trend analysis shows 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 investigation is still ongoing, a final report will be submitted upon completion.Follow up reported- d9 - device available for evaluation - date returned to manufacturer date changed form 04/13/2023 to 04/04/2023 h3 - device evaluated by manufacturer - changed from "no" to "yes" h4 - device manufacture date changed from 06/16/2022 to 01/21/2021 h6 - type of investigation code changed - removed code 4110 "trend analysis" - added code 10 "testing actual/suspected device" technical investigation concluded: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.Device investigation concluded: a short-circuit had formed inside the usb type c connector on the charger.This short-circuit created a low-ohmic connection from vbus to ground.The short-circuit will emit heat when the power supply is connected, causing up to the rated 5 w of the wall charger to be dissipated inside the connector, which deformed the housing around the connector.The clinical investigation concluded: the case involves a 78-year-old female who has reported- jabra charger burned at charging port.The person stated this has been plugged into a device with other multiple ports for months and never had an issue until yesterday.No harm to people or property.It is unknown if original accessories were used.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.This is a final report.No further follow up is expected.

• 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 (Section G): GN HEARING A/S; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• Manufacturer Contact: karen frisk ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 16817442
• Report Number: 3005650109-2023-00056
• Device Sequence Number: 16626782
• Product Code: OSM
• UDI-Device Identifier: 05708296223633
• UDI-Public: 05708296223633
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/25/2023

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: 22032400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female