MAUDE Adverse Event Report: SONOVA AG PHONAK MINI CHARGER CASE

Model Number	075301512
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that a phonak mini charger case has overheated and lead to a minor damage of the user's night table.No injury to the user or third party has been reported.The customer will receive a compensation for the damage.The device has not been received back for analysis.Similar events will be further monitored for trends.This is a late report that comes to our attention as a result of an improvement to the complaint handling procedure.
Additional Manufacturer Narrative
Despite follow up attempts in 2023 the manufacturer was not able to obtain more information from the initial reporter as stated in the initial report, the patient did not experience any injury due to this event.The issue was recognized by the patient by visual inspection of the device.The device was not returned for analysis, therefore it is not possible to conclude on the exact root cause of this incident.However, a potential root cause may be undesired ohmic connection between contacts of the usb connector, generating heat and causing the melting/burning of the cable connector housing and of the device housing close to it.The ohmic connection might be caused by damage of connector pins or shell, or by dirt, dust, debris or liquids inside the usb connector, or even just by aging due to corrosion of the metal.The device and components are in compliance with applicable electrical safety standards (i.E.Iec 60601-1, iec 60601-1-2; iec 62366; iec 62368-1).The chargers have an electronic protection against short circuits.The ac adapter enclosure is a critical component according to iec 60601-1.Subsequently, the material choice of the ac adapter is according to ul 94 safety standard, the usb-a to usb-c cable is according to ul 758 safety standard and the charger enclosure and parts are according to ul 746c safety standards.The risk file already considers and addresses the risk of overheating of the charger, electric short at charger contacts and thermal damage due to moisture.There are no unacceptable residual risks of negative side effects or clinical risks that are not outweighed by the benefits.There are no unacceptable residual risks of harm resulting from poor usability that are not outweighed by the benefits.The devices are within their specification and the issue does not pose an unacceptable health or safety risk.The user guide describes how to correctly prepare the charger for use and how to use it correctly, maintenance steps e.G.Remove dust or dirt from the charger, and warnings e.G.Hearing aids should be dry and clean before charging, the charger should be disconnected from the power before cleaning, do not cover the charger while charging, protect against shock.The case was initially reported to the manufacturer in october 2023 and phonak charger mini case was phased out in december 2021 due to marketing reasons and replacement by a new model.The manufacturer is observing similar events for trends.This is the final report.

• Brand Name: PHONAK MINI CHARGER CASE
• Common Device Name: PHONAK MINI CHARGER CASE
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa,zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisruetistrasse 28; stafa, zurich, IL 8712 ; SZ 8712 ; 6308219589
• MDR Report Key: 18535711
• Report Number: 3005085999-2024-00001
• Device Sequence Number: 7773525
• Product Code: OSM
• UDI-Device Identifier: 07613389250886
• UDI-Public: 07613389250886
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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: 075301512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 05/07/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown