MAUDE Adverse Event Report: EXTERNAL MANUFACTURER COMMUNICATOR; ACCESSORY

Model Number	6280
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, product analysis indicates that the allegation against the power cord was not confirmed.The returned power cord was not melted and was used for analysis testing.The communicator passed all baseline checks and exercises which confirmed functionality of the communicator.
Event or Problem Description
Boston scientific received information that the communicator power cord was melted.A boston scientific company representative verified no one was injured.The company representative offered to replace the power cord but the patient does not want to use the communicator anymore.The company representative advised the patient to call the physician in regards of the communicator usage.A return label will be send with the power cord.The communicator was out of service.No adverse patient effects were reported.
Additional Manufacturer Narrative
The device manufacture date for this product is september 17,2014.
Event or Problem Description
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• Brand Name: COMMUNICATOR
• Common Device Name: ACCESSORY
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• MDR Report Key: 5636545
• Report Number: 2124215-2016-03101
• Device Sequence Number: 261343
• Product Code: OSR
• UDI-Device Identifier: 00802526544118
• UDI-Public: (01)00802526544118
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2016

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: 6280
• Other Device ID Number: LATITUDE WAVE COMMUNICATOR (IS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2016
• Supplement Report FDA Received Date: 08/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1