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

Model Number	21587700
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Ref sf: (b)(4).On (b)(6) 2022: it was reported hearing aid charger and usb-c connector melted and "fused" together so the usb-c cable could not be removed and cable broke.Only original equipment was used.The rechargable hearing aids with the charger were purchased on (b)(6) 2021.The date of the incident is not available.Device is out of warranty, the clinic purchased a new device.The date of the event is not availble.No patient involvment or harm to the user reported.
Additional Manufacturer Narrative
Manufacturers reference#: (b)(4).Based on the available information, the malfunction may lead to, or might led to, death or a serious injury if it were to recur or the event / incident did lead to, or might have led to, death or a serious injury and indicates need for immediate reporting.Technical investigation concluded: device history register review have been completed.No deviation or changes were found during manufacturing of the device.The clinical investigation concluded: based on these results from previous evaluations, clinical conclusion on this case is that there is a potential risk of heat dissipation based on the findings.From the previous investigations it is concluded that the high temperatures are limited to places difficult to touch, such as the back of the charger.Clinical conclusion on the case is that, even though unpleasant, it is evaluated unlikely that the device in failure mode would cause harm, if the event was to reoccur, because of the unlikely event of contacting the difficult to touch location.Risk register will be updated to include warning/caution to the users.Further investigation pending, to be submitted when completed.
Additional Manufacturer Narrative
Manufacturers reference #(b)(4).Based on the available information, the malfunction may lead to, or might led to, death or a serious injury if it were to recur or the event / incident did lead to, or might have led to, death or a serious injury and indicates need for immediate reporting.Technical investigation concluded: device history register review have been completed.No deviation or changes were found during manufacturing of the device.The clinical investigation concluded: based on these results from previous evaluations, clinical conclusion on this case is that there is a potential risk of heat dissipation based on the findings.From the previous investigations it is concluded that the high temperatures are limited to places difficult to touch, such as the back of the charger.Clinical conclusion on the case is that, even though unpleasant, it is evaluated unlikely that the device in failure mode would cause harm, if the event was to reoccur, because of the unlikely event of contacting the difficult to touch location.Risk register will be updated to include warning/caution to the users.Further investigation pending, to be submitted when completed.
Event or Problem Description
Ref (b)(4).On 13sep2022: it was reported hearing aid charger and usb-c connector melted and "fused" together so the usb-c cable could not be removed and cable broke.Only original equipment was used.The rechargable hearing aids witht he charger were purchased on (b)(6) 2021.The date of the incident is not available.Device is out of warranty, the clinic purchased a new device.The date of the event is not availble.No patient involvment or harm to the user reported.On 09nov2022: no new information recieved.No follow up is expected.
Event or Problem Description
Ref sf (b)(4).(b)(6) 2022: it was reported hearing aid charger and usb-c connector melted and "fused" together so the usb-c cable could not be removed and cable broke.Only original equipment was used.The rechargable hearing aids with the charger were purchased on (b)(6) 21.The date of the incident is not available.Device is out of warranty, the clinic purchased a new device.The date of the event is not available.No patient involvement or harm to the user reported.09nov2022: no new information received.No follow up is expected.
Additional Manufacturer Narrative
Manufacturers reference # sf (b)(4).Based on the available information, the malfunction may lead to, or might led to, death or a serious injury if it were to recur or the event / incident did lead to, or might have led to, death or a serious injury and indicates need for immediate reporting.Technical investigation concluded: device history register review have been completed.No deviation or changes were found during manufacturing of the device.The clinical investigation concluded: based on these results from previous evaluations, clinical conclusion on this case is that there is a potential risk of heat dissipation based on the findings.From the previous investigations it is concluded that the high temperatures are limited to places difficult to touch, such as the back of the charger.Clinical conclusion on the case is that, even though unpleasant, it is evaluated unlikely that the device in failure mode would cause harm, if the event was to reoccur, because of the unlikely event of contacting the difficult to touch location.Risk register will be updated to include warning/caution to the users.Further investigation pending, to be submitted when completed.09nov2022: additional information/corrections: b3 - best estimate for data of event added, b5 - comment added, d8 - corrected, g6 - corrected, h2 - corrected, h8 - corrected.Device investigation pending, to be submitted when available.09dec2022.Additional information/corrections: b4 - date of this report updated, d9 - updated, e2 and e3 - initial reporter updated, g2 - report source updated, h3 - type of investigation code added, investigation findings and investigation conclusion codes updated.Manufacturer's investigation conclusion: trended case device investigation 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.The clinical investigation concluded (updated): based on these results from previous evaluations, clinical conclusion on this case is that there is a potential risk of heat dissipation based on the findings.From the previous investigations it is concluded that the high temperatures are limited to places difficult to touch, such as the back of the charger.Clinical conclusion on the case is that, even though unpleasant, it is evaluated unlikely that the device in failure mode would cause harm, if the event was to reoccur, because of the unlikely event of contacting the difficult to touch location.Risk register has been updated to include warning/caution to the users.Manufacture's investigation is final.Consider this 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: 15604245
• Report Number: 3005650109-2022-00049
• Device Sequence Number: 2278086
• Product Code: OSM
• UDI-Device Identifier: 05708296200337
• UDI-Public: 05708296200337
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2022

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: 21587700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 09/13/2022; 09/13/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 11/11/2022; 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown