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

Model Number	RONDO 3 AUDIO PROCESSOR [ME1550]
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
Event or Problem Description
The rondo 3 audio processor was returned severely broken.There is a substance on the device that's liquid.Received images of the device show an oxidized magnet, and also a magnet compartment with liquid residues, which clearly come from an external liquid exposure.Images of the battery show some slight oxidation of the battery contacts, which could potentially be from a leaking battery, however, due to the severely damaged device status it could also be due to external liquid.
Event or Problem Description
The rondo 3 audio processor was returned severely broken.There is a substance on the device that_s liquid.Received images of the device show an oxidized magnet, and also a magnet compartment with liquid residues, which clearly come from an external liquid exposure.Images of the battery show some slight oxidation of the battery contacts, which could potentially be from a leaking battery, however, due to the severely damaged device status it could also be due to external liquid.
Additional Manufacturer Narrative
Conclusion: according to the information received the rondo 3 audio processor was returned severely broken with a liquid substance on the housing of the device.Device investigation revealed a broken housing mots likely due to improper handling of the device.A leaking battery can be ruled out, due to the battery housing being mechanically fully intact.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: 22008764
• Report Number: 9710014-2025-00432
• Device Sequence Number: 20814125
• Product Code: MCM
• UDI-Device Identifier: 09008737392468
• UDI-Public: (01)09008737392468
• 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): 06/23/2025

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 3 AUDIO PROCESSOR [ME1550]
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/23/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown