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

Model Number	20686204
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A dhr review have been completed.No deviation or changes were found during manufacturing of the device.Parent case investigation: the rechargeable batteries in the resound linx quattro hearing aids and the hearing aid charger are lithium-ion batteries.It is recommended-avoid storing your hearing aids and hearing aids charger near sources of heat or cold.Nb: if your linx quattro, beltone amaze or preza 8 with dsw 1.0.45 or higher are getting warm for a longer period of time during charging or show much less than 16 hours battery life after full charging of at least 3 hours, it is probably a defect battery in one of the hi and you have to send the hi for service and repair.Although reported - hearing aid heated up in the charger so badly that it burnt the patient's finger when she removed from charger enough to turn her finger red where she made contact.This has not been confirmed with pictures or further information.This is an initial report.
Event or Problem Description
(b)(4).It has been reported- hearing aid heated up in the charger so badly that it burnt the patient's finger when she removed from charger enough to turn her finger red where she made contact.No further information available regarding pictures, treatment, etc.This is an initial report.
Event or Problem Description
Manufacturer's ref: sf (b)(4).It has been reported- hearing aid heated up in the charger so badly that it burnt the patient's finger when she removed from charger enough to turn her finger red where she made contact.No further information available regarding pictures, treatment, etc.This is a final report.
Additional Manufacturer Narrative
Manufacturer's ref# sf (b)(4).Follow up: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.Parent case investigation: the rechargeable batteries in the resound linx quattro hearing aids and the hearing aid charger are lithium-ion batteries.It is recommended-avoid storing your hearing aids and hearing aids charger near sources of heat or cold.Nb: if your linx quattro, beltone amaze or preza 8 with dsw 1.0.45 or higher are getting warm for a longer period of time during charging or show much less than 16 hours battery life after full charging of at least 3 hours, it is probably a defect battery in one of the hi and you have to send the hi for service and repair.Although reported - hearing aid heated up in the charger so badly that it burnt the patient's finger when she removed from charger enough to turn her finger red where she made contact.This has not been confirmed with pictures or further information.Risk will update to include warning/caution to the users.Clinical conclusion on the case is that, even though unpleasant, risk of high temperature and burn are mitigated by extensive safety testing according to standards according to master risk list.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.Based on the above information, the case is considered not reportable as the event / incident did not lead to, or might led to, death or a serious injury.H6: 4581 appropriate term/code not available used since there was no confirmation of the reported burn.It is a female patient.This is a final report.No further information 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 Contact: karen frisk ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 15493452
• Report Number: 3005650109-2022-00041
• Device Sequence Number: 1793061
• Product Code: OSM
• UDI-Device Identifier: 05708296145362
• UDI-Public: 05708296145362
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 20686204
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2019
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female