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

Model Number	21303874
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history register review have been completed and showed no deviation or changes found during manufacturing of the device.Investigation results are pending.
Event or Problem Description
Around (b)(6) 2022 the patient's friend noticed a flashed bright light, spark in the patient's ear canal, and the patient experienced an electric/static shock.The patient have not been in contact with an authorized medical practitioner.
Additional Manufacturer Narrative
15-jul-2022, a device history register review have been completed and showed no deviation or changes found during manufacturing of the device.Investigation results are pending.16-aug-2022: investigation of device performed and found: the devices show no sign of deformed outer shells the device could be booted up and connected as well as controlled by the resound smart 3d app.The device can play directly streamed music from a compatible android phone.The device has a battery level of 3/5 led's when left 16 hours on the desk no signs of mechanical or electrical problems observed with the receiver assembly and ng8 connector.The final conclusion of the investigation: no problems can be found.19-aug-2022: final reportability rationale: technical investigation concluded: no deviation or changes were found during manufacturing of the device.Devices were sent in for investigation.The devices show no sign of deformed outer shells.The device could be booted up and connected as well as controlled by the resound smart 3d app.The device can play directly streamed music from a compatible android phone.The device has a battery level of 3/5 led's when left 16 hours on the desk.No signs of mechanical or electrical problems observed with the receiver assembly and ng8 connector.The final technical conclusion: no problems can be found.The clinical investigation concluded: the perceived electric shock can perhaps be uncomfortable, but the voltage is too low to be able to cause any serious injury to the patient, user or other person and would not if it were to recur.The devices were manufactured to accepted specifications.Electric shock from hearing aids is identified in the risk analysis and is mitigated to an acceptable level, as voltage in hearing aids is too low to cause harm.Clinical conclusion on the case is that even though unpleasant, this experience cannot cause harm.Risk register 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 based on the above investigation the reportability assessment has been reassessed to not reportable, as the event / incident did not lead to, or might led to, death or a serious injury if to recur.Corrected data: model number.Codes updated in h6.Consider this as final report.
Event or Problem Description
Around on (b)(6) 2022, the patient's friend noticed a flashed bright light, spark in the patient's ear canal, and the patient experienced an electric/static shock.The patient have not been in contact with an authorized medical practitioner.19-aug-2022, no additional follow up information received.Consider this as 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: 15025977
• Report Number: 3005650109-2022-00011
• Device Sequence Number: 20106202
• Product Code: OSM
• UDI-Device Identifier: 05708296194568
• UDI-Public: 05708296194568
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 21303874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• 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