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

Model Number	20472100
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).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.
Event or Problem Description
It was reported, charger, cable and adapter melted at night ((b)(6) 2023) during charging and triggered the fire alarm.It did not caught fire.It happened to the charger.While plugged to the electric system.Unoriginal equipment was used.No harm or property damage reported.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).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.(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.Trended case concluded: the connector is broken, probably because the user has (not intentionally) misused it, while inserting the cable.If the cable has been slightly out of specification that could have had a negative effect on this.This has caused a low ohmic connection in the cable connector - almost a short circuit - that will emit heat when the cable is inserted into the wall charger, causing up to the rated 5 w of the wall charger to be dissipated inside the connector.Micro usb is a very well known and used standard but can mechanically break down.Device investigation: a short-circuit had formed inside the usb type c connector on the charger.The short-circuit can be formed by the contaminants at bottom of the connector.But signs of wear and tear are also present.The short-circuit was created by a low-ohmic connection from vbus to ground.The short-circuit will emit heat when the power supply is connected.The power supply used with the charger was non-gn equipment, the cable used was gn equipment.The power supply used is "ka1517-0501500euu' from [?]shenzhen keyu power supply technology co.,ltd'.The power supply was rated 7.5 watt and could therefore dissipate more heat into the connector.The non-gn ac-adapter, has failed.This failure has a part in, what the user describes as triggering the fire alarm.The ac-adapter should under a stress situation not fail, like the one used here.The clinicaal investigation concluded: it has been reported that "charger, cable and adapter melted at night during charging and triggered the fire alarm'.Original charger and cable used, but adapter is not original.R&d investigation concluded that the original ac-adapter should under a stress situation not fail, like the unoriginal one used here.No personal harm or property damage reported.The chargers have been tested according to applicable safety standards.These risks are reduced as far as possible and the probability of occurrence of these events is considered very low.In case of moisture, sweat or dirt in the connector, there can be high temperatures inside the connector due to power dissipation when connected to the charger plug.There can be melting of the plastic around the connector and is visible to the naked eye.It is highly unlikely that the user would touch in case there appears to be melting or high temperatures.In the unlikely event of the user touching this overheated device, it can lead to superficial or minor injury that would in most cases require no medical intervention.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 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.
Event or Problem Description
It was reported, charger, cable and adapter melted at night (b)(6)2023 - (b)(6) 2023) during charging and triggered the fire alarm.It did not caught fire.It happened to the charger.While plugged to the electric system.Unoriginal equipment was used.No harm or property damage reported.

• 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: 16944333
• Report Number: 3005650109-2023-00066
• Device Sequence Number: 17736439
• Product Code: OSM
• UDI-Device Identifier: 05708296147113
• UDI-Public: 05708296147113
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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
• Report Date (Section B): 06/15/2023

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: 20472100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2018
• 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 Age: 80 YR
• Patient Sex: Male