MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH RONDO; EXTERNAL COMPONENT

Model Number	RONDO 2 AUDIO PROCESSOR [BUTTON PROCESSOR 2]
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to med-el hq where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.
Event or Problem Description
User reported that while charging, the device started to heat up and smoke.
Event or Problem Description
User reported that while charging, the device started to heat up and smoke.
Additional Manufacturer Narrative
Conclusion: according to the information received the rondo 2 audio processor heated up and smoked while charging.Damage from heating can be confirmed as visible damage in form of deformed housing parts.However, while testing the device with a charger and the electrical battery measurement no heating or smoke could be observed.Also by observing the damage of the housing parts it can be assumed that the heating damage occurred due to an external heat source since no visible damage inside the device was found on the rechargeable battery, circuit board and its components.Additionally residues of an unknown liquid and traces of an adhesive were found inside the device.This is a final report.

• Brand Name: RONDO
• Common Device Name: EXTERNAL COMPONENT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 23140841
• Report Number: 9710014-2025-00891
• Device Sequence Number: 9961178
• Product Code: MCM
• UDI-Device Identifier: 09008737304591
• UDI-Public: (01)09008737304591
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: RONDO 2 AUDIO PROCESSOR [BUTTON PROCESSOR 2]
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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