MAUDE Adverse Event Report: EXTERNAL MANUFACTURER COMMUNICATOR; ACCESSORY

Model Number	6290
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.
Event or Problem Description
Boston scientific received information that the communicator was emitting smoke.A boston scientific company representative instructed to unplug the power cord and the communicator was no longer working.The company representative opted for a communicator replacement and a return label will be sent.The communicator is no longer in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the allegation towards the monitor during baseline tests was not confirmed.There was no smoke emitting from the communicator and the server call was not completed.There were no error logs found and a successful interrogation was performed.The product performance engineers opened the communicator and there were no signs of the burnt components.

• Brand Name: COMMUNICATOR
• Common Device Name: ACCESSORY
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• MDR Report Key: 6283353
• Report Number: 2124215-2016-21578
• Device Sequence Number: 663459
• Product Code: OSR
• UDI-Device Identifier: 00802526570322
• UDI-Public: (01)00802526570322(11)20150508
• 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): 08/04/2017

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: 6290
• Other Device ID Number: LATITUDE WAVE COMMUNICATOR (MI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 12/01/2016
• Supplement Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 01/27/2017
• Supplement Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4); (B)(4); (B)(4); (B)(4)
• Patient Age: 50 YR