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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM; EXTERNAL COMPONENT
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MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM; EXTERNAL COMPONENT Back to Search Results
Model Number FINETUNER ECHO [FINETUNER 2]
Device Problem Circuit Failure (1089)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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 Description
A finetuner echo was returned to service and repair.Upon preliminary investigation at service and repair it was determined that there is failure of the tantalum capacitor.According to the repair request form, the device had no function.No injury has been reported.
 
Event Description
A finetuner echo was returned to service and repair.Upon preliminary investigation at service and repair it was determined that there is failure of the tantalum capacitor.According to the repair request form, the device was mechanically not functioning.No injury has been reported.
 
Manufacturer Narrative
Conclusion: according the information received, a finetuner echo was sent to service _ repair due to mechanical problems.During device investigation a failed capacitor was detected which was clearly the reason for the reported issue.Electrical inspection could not be performed because of the observed malfunction.No injury was reported.This is a final report.
 
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Brand Name
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
Type of Device
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 Key18892159
MDR Text Key337752315
Report Number9710014-2024-00227
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09008737344290
UDI-Public(01)09008737344290
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
P000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/20/2024
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
Device Operator Lay User/Patient
Device Model NumberFINETUNER ECHO [FINETUNER 2]
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/05/2024
Initial Date FDA Received03/13/2024
Supplement Dates Manufacturer Received03/05/2024
Supplement Dates FDA Received03/21/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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