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

Model Number	20623200
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Manufacturer's ref# (b)(4).It has been reported- the cord and the port where the cord plugs in has melted.Follow up information recieved on 21-dec-2022: no patient harm has occurred, and no contact with authorised medical practitioner it happened on or around (b)(6) 2022.The device was placed on the table pugged in hearing care professional recommended to send in the charger and not leave plugged in when not in use.Original accessories have been used.Unknown battery make.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.Trend anaysis conclsion: 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.A final report will be submitted when other assessments are done.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4) technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.Trend anaysis conclsion: 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.26jan2023: correction: trended case conclusion from the initila report (above) is a mistake.See below conlusion for the right connector type.Trended case conclusion: functional testing reveals that the charger works fine, when running on the internal battery.That means that the malfunction in the device is purly a breakdown of the micro usb connector.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.The risk is identified, a known risk, mitigated through compliance to safety standards.Clinical evaluation: the case involves a hearing aid charger cord and the charger port melting at the connector.There has been no patient harm.Original charger and cord were used.Based on the result from r&d investigation from trended case, clinical conclusion on the case is that there is a potential risk of heat dissipation based on the findings.A damaged power supply or a power supply of very poor quality could lead to burn injuries and in rare conditions there is a small risk that a wrong charging or discharging or a battery thermal runway can lead to high temperatures or fire accidents.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.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.This is a final report.No follow up is further expected.
Event or Problem Description
Manufacturer's ref# (b)(4) it has been reported- the cord and the port where the cord plugs in has melted.Follow up information received on 21-dec-2022: no patient harm has occurred, and no contact with authorised medical practitioner it happened on or around (b)(6) 2022 the device was placed on the table pugged in hearing care professional recommended to send in the charger and not leave plugged in when not in use original accessories have been used unknown battery make follow up: correction as the trended case was incorrect.This is a micro usb connector.No further follow up information expected.

• Brand Name: BELTONE IMAGINE
• Common Device Name: HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
• Manufacturer (Section D): GN HEARING A/S; lauprupbjerg 7; ballerup, 2750 ; DA 2750
• Manufacturer Contact: karen frisk ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 16059258
• Report Number: 3005650109-2022-00084
• Device Sequence Number: 8427020
• Product Code: OSM
• UDI-Device Identifier: 05708296147120
• UDI-Public: 05708296147120
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 01/26/2023

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: 20623200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2019
• 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