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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 Problems No Device Output (1435); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
 
Event Description
The finetuner echo (fte) would no longer power on and the screen would freeze.There was a clacking noise caused by a potential loose component when the device was shaken.Furthermore, there is also a bulge in the plastic on the back where the serial number is printed.The recipient received a new device.
 
Event Description
The finetuner echo (fte) would no longer power on and the screen would freeze.There was a clacking noise caused by a potential loose component when the device was shaken.Furthermore, there is also a bulge in the plastic on the back where the serial number is printed.Cr2032 batteries were used, these were exchanged and the device would work again but still showed a weak battery.The recipient received a new device.
 
Manufacturer Narrative
Conclusion: according the information received, the finetuner echo would no longer power on and the screen would freeze.Furthermore the housing was bulged.During device investigation a defective 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.No injury was reported.
 
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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 Key15842116
MDR Text Key304554943
Report Number9710014-2022-00895
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09008737344290
UDI-Public(01)09008737344290
Combination Product (y/n)N
Reporter Country CodeGM
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 02/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2022
Is this an Adverse Event Report? Yes
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
Was the Report Sent to FDA? No
Date Manufacturer Received11/21/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age55 YR
Patient SexFemale
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