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

Model Number	AUDIO LINK MAIN UNIT [WIRELESS RELAY MAIN UNIT]
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Audiolink main unit including battery and docking station we recently received which have a burned usb port.
Event or Problem Description
Audiolink main unit including battery and docking station were received by service and repair with a burned usb port.The main unit was put in the docking station and the user found it with the damage in the morning.
Additional Manufacturer Narrative
Conclusions: devices investigation confirmed the presence of a burnt usb port and signs of burn on the housing of audiolink main unit, battery compartment and docking station.Based on the dried liquid residues observed on the housing parts, it must be assumed that the devices were exposed to excessive amounts of moisture i.E.Liquid and a short circuit occurred.However, further internal testing could not reproduce the observed level of damage, namely the scenario where these short circuits might lead to a critical temperature development could not be repeated.This is a final report.

• 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: 12757881
• Report Number: 9710014-2021-00840
• Device Sequence Number: 4254380
• Product Code: MCM
• UDI-Device Identifier: 09008737370282
• UDI-Public: (01)09008737370282
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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: AUDIO LINK MAIN UNIT [WIRELESS RELAY MAIN UNIT]
• Device Catalogue Number: 37028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 42 YR
• Patient Sex: Female