MAUDE Adverse Event Report: EXTERNAL MANUFACTURER COMMUNICATOR; ACCESSORY

Model Number	6280
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory product analysis indicates that the communicator power cord had an anomaly upon visual analysis.The communicator power brick was severed.The power brick was returned only.The power brick was broken in several locations.The returned power brick measured zero voltage upon testing.
Event or Problem Description
Boston scientific received information that the communicator power cord had an anomaly.Boston scientific company representative verified that the outlet portion of the communicator power cord was broken and the wire was observed to be burned.The company representative verified that there was no reported damage to any property.The company representative advised the patient for a power cord replacement.Additional information from the product analysis indicates that the allegation against the communicator power cord was confirmed.The communicator power brick was broken in several locations.Additional information also indicates that there was zero voltage upon testing on the power cord.The communicator remains in service.No adverse patient effects were reported.

• Brand Name: COMMUNICATOR
• Common Device Name: ACCESSORY
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• MDR Report Key: 7989215
• Report Number: 2124215-2018-13911
• Device Sequence Number: 288619
• Product Code: OSR
• UDI-Device Identifier: 00802526577307
• UDI-Public: 00802526577307
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 10/22/2018
• 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: 0184; E102
• Patient Age: 67 YR