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

Model Number	21625000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6)2023, it was reported that the charger cord is pulling out, and smells like fire.Hearing care provider stated that incident had caused any harm.Original accessories were not used.Further follow up information is expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).(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.Device investigation, clinical assessment and risk register conclusion pending, will be submitted on completion this is an initial report.
Additional Manufacturer Narrative
Manufacturer's ref# sf (b)(4).21jun2023: technical investigation concluded: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.Device investigation, clinical assessment and risk register conclusion pending, will be submitted on completion.This is an initial report.21jun2023: this is an initial - correction report due to the error below.B5- sentence "hearing care provider stated that incident had caused any harm." has been corrected to "hearing care provider stated that incident had not caused any harm." by a human error the word "not" was missing at the initial report.20jul2023: trended case 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.Device investigation confirm trend case conclusion.Furthermore, device investigation concluded: the short-circuit will emit heat when the cable is connected to the wall charger.The power supply used with the charger might not have been a gn supplied power supply.Thus, the power dissipated in the connector can have been more than the rated 5 w of the gn power supply.Risk register conclusion 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.Manufacturer's investigation is final.This is a final report.No further follow up is expected.11aug23: this case is late due to human error in its execution and submission.Manufacturer has identified and corrected through nc-02530.
Event or Problem Description
21jun2023: it was reported that the charger cord is pulling out, and smells like fire.Hearing care provider stated that incident had not caused any harm.Original accessories were not used.Further follow up information is expected.20jul2023: no further follow up has been received.
Event or Problem Description
21jun2023 : it was reported that the charger cord is pulling out, and smells like fire.Hearing care provider stated that incident had not caused any harm.Original accessories were not used.Further follow up information is expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).21jun2023 : technical investigation concluded: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.Device investigation, clinical assessment and risk register conclusion pending, will be submitted on completion this is an initial report.21jun2023 : this is an initial - correction report due to the error below.B5- sentence "hearing care provider stated that incident had caused any harm." has been corrected to "hearing care provider stated that incident had not caused any harm." by a human error the word "not" was missing at the initial report.11aug2023 : this case is late due to human error in its execution and submission.Manufacturer has identified and corrected through nc-02530.

• 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: 17169016
• Report Number: 3005650109-2023-00079
• Device Sequence Number: 7038816
• Product Code: OSM
• UDI-Device Identifier: 05708296200061
• UDI-Public: 05708296200061
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2023

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: 21625000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 05/22/2023; 05/22/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 08/11/2023; 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Female