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 Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the allegation against the power cord was confirmed.The returned power adapter was unable to give power to the communicator due to an internal anomaly.The measurement showed the returned adapter¿s output voltage was out of specification.The green light emitting diode (led) light did not turn on.The blade adapter plate was removed.There was no arc mark on either of the blade contacts or power prongs.However, the plastic was melted around one of the power blades.An internal anomaly caused the power adapter to draw an excessive amount of current causing the heat buildup in the metal power prong which melted the plastic.
Event or Problem Description
Boston scientific received information that the power cord had no light.A boston scientific company representative verified that the communicator was plugged into a working power outlet.The power cord will be replaced and a return label will be sent.The company representative advised the patient advocate to call back if the new power cord will not fix the issue.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: 7368993
• Report Number: 2124215-2018-04114
• Device Sequence Number: 13470106
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 02/13/2018

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
• Other Device ID Number: LATITUDE WAVE COMMUNICATOR (IS
• 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: 02/13/2018
• Initial Report FDA Received Date: 03/26/2018
• 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: 0295; 4469; E142
• Patient Age: 65 YR