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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 SONNET CHARGING UNIT [OPUS 3 CHARGER]
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
The device was received at service _ repair.Upon preliminary investigation the returned sonnet charging unit has a burnt usb socket.There was no report of any injury, however further information is not available.
 
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
The device was received at service _ repair.Upon preliminary investigation the returned sonnet charging unit has a burnt usb socket.There was no report of any injury, however further information is not available.
 
Manufacturer Narrative
Conclusion: the device was received at service _ repair.Based on the received information, the sonnet charging unit has a burnt usb socket.Upon investigation an insect body part was found between two contacts at the socket inside the device which most likely caused the burning of the usb socket.There was no report of any injury.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 Key18168134
MDR Text Key328514965
Report Number9710014-2023-01038
Device Sequence Number1
Product Code MCM
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
Date FDA Received11/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberSONNET CHARGING UNIT [OPUS 3 CHARGER]
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2023
Was the Report Sent to FDA? No
Date Manufacturer Received11/08/2023
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
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