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

Model Number	19706708
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Sf: (b)(4).It was reported- aids put in dry jar and melted.Customer verified the jar was not resound brand.They believe the heat element in the jar caused the melting and therefore was not related to the resound aids, but no specific investigation was done' the current information indicates need for immediate reporting.Based on the available information, the event/ incident did lead to, or might led to, death or a serious injury if it were to recur.This is an initial report.
Additional Manufacturer Narrative
Sf: (b)(4).A dhr review have been completed.No deviation or changes were found during manufacturing of the device.It has been reported- not enough information how the ha got melted in the dry jar.Aid physically melted and broken into pieces.Technical investigation: most drying jars can dry aids in surroundings up to 50-60 degrees.If the hearing aids are turned off, it is fine to use dry jars.A dry box can be used for all types of gn hearing aids.It is suspected that the aids were left in the dry box subjected to surroundings with excessive heat.This is an initial report.
Event or Problem Description
(b)(6).It was reported- aids put in dry jar and melted.Customer verified the jar was not resound brand.They believe the heat element in the jar caused the melting and therefore was not related to the resound aids, but no specific investigation was done'.The current information indicates need for reporting.Based on the available information, the event/ incident did lead to, or might led to, death or a serious injury if it were to recur.This is a final report.
Additional Manufacturer Narrative
(b)(6).A dhr review have been completed.No deviation or changes were found during manufacturing of the device.It has been reported- not enough information how the ha got melted in the dry jar.Aid physically melted and broken into pieces.Technical investigation: most drying jars can dry aids in surroundings up to 50-60 degrees.If the hearing aids are turned off, it is fine to use dry jars.A dry box can be used for all types of gn hearing aids.It is suspected that the aids were left in the dry box subjected to surroundings with excessive heat.Clinical evaluation of the event: case information states that the devices melted while placed in a drying jar.The jar is not a gn hearing product, and the patient reports that the heating element in the drying jar may have caused the melting.No patient harm was reported, as the devices were in the drying jar and not in the patient's ears.Device user guide has a warning how to dry the devices.Risk analysis already included, the residual risk after the risk control measure(s) is acceptable.This is a final report.No further information 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 Contact: karen frisk ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 15452954
• Report Number: 3005650109-2022-00035
• Device Sequence Number: 20551418
• Product Code: OSM
• UDI-Device Identifier: 05704819289933
• UDI-Public: 05704819289933
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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: 19706708
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2020
• 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