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

Model Number	RT5CIC-MP
Medical Device Problem Codes	Burst Container or Vessel (1074); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# sf (b)(4).24-feb-2023: technical investigation concluded: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.Awaiting device investigation.Investigation is still in progress; a final report will be submitted upon completion.
Event or Problem Description
24-feb-2023: on an unknown date ((b)(6) 2023 best estimate), it was reported 'battery explodes inside of hearing aid'.The patient was changing the battery when he noticed a pop.He never had the device in his ear, so there was no injury.The battery was in his hand at the time.
Event or Problem Description
On (b)(6) 2023: on an unknown date on (b)(6) 2023 best estimate), it was reported 'battery explodes inside of hearing aid'.The patient was changing the battery when he noticed a pop.He never had the device in his ear, so there was no injury.The battery was in his hand at the time.On (b)(6) 2023: 3 attempts were made to receive follow up information.No further follow up information is expected.
Additional Manufacturer Narrative
Manufacturer's ref#: (b)(4).On (b)(6) 2023: technical investigation concluded: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.Awaiting device investigation.Investigation is still in progress; a final report will be submitted upon completion.On (b)(6) 2023: corrected section g2 and d3.Awaiting device investigation.Investigation is still in progress; a final report will be submitted upon completion.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).24-feb-2023: technical investigation concluded: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.Awaiting device investigation.Investigation is still in progress; a final report will be submitted upon completion.23-mar-2023: corrected section g2 and d3.Awaiting device investigation.Investigation is still in progress; a final report will be submitted upon completion.18-apr-2023: device investigation conclusion: the returned hearing aid shows no signs of deformation or discoloration and the battery of the returned hearing aid is in good condition, with no signs of swelling, leakage, rupture or explosion.Device is currently in a functional condition and performs in accordance with the specifications.The clinical investigation concluded: the clinical evaluation does evaluate electrical related risks, leakage or overheating with the battery and the user guide includes a safety notification on handling of batteries.However, the device investigation showed no deformation/explosion with the battery or hearing aid.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: the residual risk after the risk control measure(s) is acceptable.No new hazardous situations revealed and no need to update the risk register.Manufacturer's investigation is final.This is a final report.
Event or Problem Description
On 24-feb-2023: on an unknown date ((b)(6) 2023 best estimate), it was reported 'battery explodes inside of hearing aid'.The patient was changing the battery when he noticed a pop.He never had the device in his ear, so there was no injury.The battery was in his hand at the time.On 23-mar-2023: 3 attempts were made to receive follow up information.No further follow up 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: 16435192
• Report Number: 3005650109-2023-00024
• Device Sequence Number: 3126920
• Product Code: OSM
• UDI-Device Identifier: 05708296246700
• UDI-Public: 05708296246700
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2023

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: RT5CIC-MP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Supplement Date Received by Manufacturer: 01/27/2023; 01/27/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 04/03/2023; 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/25/2022
• 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: Male