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	06/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
Boston scientific received information that the communicator's original power cord emitted a smoke.A boston scientific company representative verified that no one was hurt and confirmed that the patient attempted to set up the communicator but was unsuccessful.The company representative then sent a new power cord to the patient and advised to call back for set up assistance.The communicator remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the allegation was confirmed as the power adapter had a severely burned transient voltage suppressor part.The damaged part was likely due to an electrical overstress and the smoke smell was not caused by the returned power adapter.The communicator failure in the patient environment was induced.
Event or Problem Description
Boston scientific received information that the communicator's original power cord emitted a smoke.A boston scientific company representative was informed that the patient attempted to set up the communicator but was unsuccessful and verified that nobody was injured.The company representative also confirmed that the power cord was disposed and advised the patient to call back for set up assistance after receiving the replacement power cord.Additional information indicated that the communicator was set up but the phone does not work and the communicator did not power on.The patient stated that there was a burning smell on the power cord.The company representative checked if the communicator was connected to a working outlet and verified that there was a steady light on the power cord.The issue was not resolved after troubleshooting was completed.The company representative then sent a return label and a replacement communicator to the patient.The communicator was deactivated.No adverse patient effects were reported.

• Brand Name: COMMUNICATOR
• Common Device Name: ACCESSORY
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• MDR Report Key: 6680652
• Report Number: 2124215-2017-10847
• Device Sequence Number: 1973125
• Product Code: OSR
• UDI-Device Identifier: 00802526577451
• UDI-Public: (01)00802526577451(11)20160428
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2017

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: 07/07/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 07/26/2017
• 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: 0295; 4136; 4470; G148; MISMATCH; S603
• Patient Age: 68 YR