MAUDE Adverse Event Report: JABIL CIRCUIT (SHANGHAI) LTD LATITUDE COMMUNICATOR

Model Number	6280
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2019
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.The product was not returned since the patient thrown the communicator away.
Event or Problem Description
It was reported that the communicator experienced smoke or fire coming out of the universal service bus (usb) ports.The patient had the monitor packed in storage because she was moving and the clinic asked her to take it out and send in a reading, when she plugged in the monitor there were no lights on.The patient then smelt smoke and noticed it was coming out of the usb ports.The patient unplugged the monitor and there were no damages or injuries.The patient does not have the monitor anymore.The clinic gave her a new one and she discarded the old monitor.

• Brand Name: LATITUDE COMMUNICATOR
• Common Device Name: COMMUNICATOR
• Manufacturer (Section D): JABIL CIRCUIT (SHANGHAI) LTD; 600 tian lin rd; shanghai ; CH
• MDR Report Key: 9212459
• Report Number: 2124215-2019-18665
• Device Sequence Number: 10839321
• Product Code: LWS
• UDI-Device Identifier: 00802526570209
• UDI-Public: 00802526570209
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P910077/S140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2019

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
• Device Catalogue Number: 6280
• Device Lot Number: 5060807
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 10/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR