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

Model Number	22421100
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).On investiagtion of the photo of the charger, the port looks melted.The trend analysis shows the the usb-c connector breaks down mechanically.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: user was "trying to get used to the hearing aids" so doesn't wear every day - in fact leaves them in charger, plugged into a power strip for 3-4 days.She now reports a "burning smell and the aids are hot" and no longer turn on.No further information reported.
Event or Problem Description
It was reported: user was "trying to get used to the hearing aids" so doesn't wear every day - in fact leaves them in charger, plugged into a power strip for 3-4 days.She now reports a "burning smell and the aids are hot" and no longer turn on.No further information reported.
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 breaks down mechanically.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.22jun2023 follow up reported: b3 - added date 04/01/2023 b4 - updated date to 06/22/2023 g6 - changed to "follow up" and added fu number "1" h2 - ticked "additional information" h3 - device evaluated by manufacturer - changed to "yes" h4 - device manufacture date changed from 11/03/2022 to 01/06/2023 h6 - type of investigation added code "10 - testing of 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.Trended case concluded: 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.Device investigation confirm trended case conclusion.Clinical assessment conclusion clinical evaluation: it is reported that the user experienced a burning smell from the charger, and that the hearing aids are hot and no longer turn on.User does not wear hearing aids every day, and leaves them in the charger, plugged into power strip for 3-4 days.There was no report of harm to the user, and no reported property damage.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.This is a final report.No further follow up 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: karen frisk ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 17001397
• Report Number: 3005650109-2023-00067
• Device Sequence Number: 20404745
• Product Code: OSM
• UDI-Device Identifier: 05708296255153
• UDI-Public: 05708296255153
• 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): 06/22/2023

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: 22421100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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