MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM; 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)
Type of Reportable Event	Malfunction
Event or Problem Description
A rondo 3 audio processor was received at service _ repair.Upon preliminary inspection a broken housing and leaking rechargeable battery was found.Per repair request form, the device was returned due to mechanical problems.To date there has been no report of injury from the field as a result of the 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.
Additional Manufacturer Narrative
Conclusion: a rondo 3 audio processor was sent to service _ repair due to mechanical problems.During the repair process a leaking battery was detected.The housing parts show heavy damage and parts of them are missing.It can be assumed that the damage to the rechargeable battery inside is caused due to mechanical stress.So far, no contact to leaking electrolyte and no patient injury from contact with leaking electrolyte was reported.This is a final report.
Event or Problem Description
A rondo 3 audio processor was received at service _ repair.Upon preliminary inspection a broken housing and leaking rechargeable battery was found.Per repair request form, the device was returned due to mechanical problems.There were no reports of the device leaking at the day of the replacement, there was no reported injury.To date there has been no report of injury from the field as a result of the leaking battery.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• 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: 18493373
• Report Number: 9710014-2024-00029
• Device Sequence Number: 3665035
• 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): 02/19/2024

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: 01/08/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/19/2024
• 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: 35 MO
• Patient Sex: Female