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	Fluid/Blood Leak (1250)
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
Device was received at service_repair on (b)(6) 2024 due to mechanical problems.Upon first investigation, a leaking battery and a broking welding seam were identified.
Additional Manufacturer Narrative
Conclusion: based on the information received, the users rondo 2 audio processor had mechanical problems.The investigation revealed a leaking battery and a damaged housing.The electrolyte had oxidized several internal components.The damage to the rechargeable battery was most likely a result of substantial mechanical stress.There have been no reported cases of patient injury from contact with the leaking electrolyte to date.This is a final report.
Event or Problem Description
Device was received at service_repair on 19-aug-2024 due to mechanical problems.Upon first investigation, a leaking battery and a broking welding seam were identified.

• 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: 20180828
• Report Number: 9710014-2024-00833
• Device Sequence Number: 12994493
• 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): 10/10/2024

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 2 AUDIO PROCESSOR [BUTTON PROCESSOR 2]
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/10/2024
• 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: 26 YR
• Patient Sex: Male