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

Model Number	21790400
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# sf (b)(4): 05-oct-2022: preliminary findings: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.Clinical conclusion: from the previous investigations it is concluded that the high temperatures are limited to places difficult to touch, such as the back of the charger.Clinical conclusion on the case is that, even though unpleasant, 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 reference: the residual risk after the risk control measure(s) is acceptable.Risk will update to include warning/caution to the users.Investigation is still in progress, a final report will be submitted upon completion.
Event or Problem Description
The charger melted where the cold plugs in.It was hot to the touch.No personal injury or property damage sustained.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4): 05-oct-2022: preliminary findings: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.Clinical conclusion: from the previous investigations it is concluded that the high temperatures are limited to places difficult to touch, such as the back of the charger.Clinical conclusion on the case is that, even though unpleasant, 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 reference: the residual risk after the risk control measure(s) is acceptable.Risk will update to include warning/caution to the users.Investigation is still in progress, a final report will be submitted upon completion.01-nov-2022: still awaiting investigation of device.A final report will be submitted upon completion.30-nov-2022: d8, g2 corrected.Trended case investigation conclusion: 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.The current information still indicates need for reporting.Based on the available information, the malfunction might led to, death or a serious injury if it were to recur.This is a final report.No further follow up expected.
Event or Problem Description
On an unknown date ((b)(6) 2022 best estimate) the charger melted where the cord plugs in.It was hot to the touch.No personal injury or property damage sustained.
Event or Problem Description
On an unknown date the charger melted where the cold plugs in.It was hot to the touch.No personal injury or property damage sustained.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).05-oct-2022: preliminary findings: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.Clinical conclusion: from the previous investigations it is concluded that the high temperatures are limited to places difficult to touch, such as the back of the charger.Clinical conclusion on the case is that, even though unpleasant, 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 reference: the residual risk after the risk control measure(s) is acceptable.Risk will update to include warning/caution to the users.Investigation is still in progress, a final report will be submitted upon completion.01-nov-2022: still awaiting investigation of device.A final report will be submitted upon completion.

• Brand Name: BELTONE
• 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: 15548968
• Report Number: 3005650109-2022-00048
• Device Sequence Number: 16595840
• Product Code: OSM
• UDI-Device Identifier: 05708296214457
• UDI-Public: 05708296214457
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2022

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: 21790400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 09/07/2022; 09/07/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 11/04/2022; 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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