MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM; EXTERNAL COMPONENT

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

A sonnet charging unit was received at service and repair with a burned usb port.

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.

Manufacturer Narrative

Conclusion: a sonnet charging unit was sent to service _ repair because of malfunction.During device investigation a burned socket was detected which was clearly the reason for the reported issue.Electrical inspection could not be performed because of the observed failure.It must be assumed that the mentioned behaviour was caused by a bad contact in the socket of the charger due to a conductive substance e.G.Sweat/dirt.This is a final report.

Event Description

A sonnet charging unit was received at service and repair with a burned usb port which reportedly came back from a user.There was no report of an injury.

• 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 Key: 17582533
• MDR Text Key: 321517585
• Report Number: 9710014-2023-00717
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SONNET CHARGING UNIT [OPUS 3 CHARGER]
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1