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

Model Number	RONDO 3 AUDIO PROCESSOR [ME1550]
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The rondo 3 audio processor was received at service repair.Preliminary inspection revealed broken housing and leaking battery.
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
The rondo 3 audio processor was received at service repair.Preliminary inspection revealed broken housing and leaking battery.
Additional Manufacturer Narrative
Conclusion: during the repair process of a rondo 3 audio processor, a leaking battery was detected.The electrolyte corroded the silicone sleeve of the battery and oxidized a few parts.The damage was most likely caused by strong mechanical stress.There have been no reports of patient injury from contact with leaking electrolyte.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: 19379819
• Report Number: 9710014-2024-00463
• Device Sequence Number: 7619891
• 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): 07/08/2024

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
• Date Returned to Manufacturer: 04/11/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 07/08/2024
• 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 Age: 13 YR
• Patient Sex: Female