MAUDE Adverse Event Report: JABIL CIRCUIT (SHANGHAI) LTD LATITUDE COMMUNICATOR; EXTERNAL 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	05/11/2020
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
It was reported that the patient was painting and a smoke is coming out of the communicator and the power adapter.The company representative opted to send a new communicator.The communicator is no longer in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the patient was painting, and a smoke is coming out of the communicator and the power adapter.The company representative opted to send a new communicator.The communicator is no longer in service.No adverse patient effects were reported.The product investigation confirmed the allegation as a burning smell and smoke seen coming from the power adapter.An incorrect power adapter is plugged into the communicator that caused the observation.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, additional information from product analysis indicates that the allegation against the power adapter was confirmed.An incorrect power adapter is plugged into the communicator that caused the observation.As there is no reportable allegation against the communicator itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.This supplemental report is being filed to correct the b5: event narrative, g4: bsc aware date (additional information aware date), h3: device evaluation by manufacturer and device not eval by mfr code and h10: additional mfr narrative.

• Brand Name: LATITUDE COMMUNICATOR
• Common Device Name: EXTERNAL COMMUNICATOR
• Manufacturer (Section D): JABIL CIRCUIT (SHANGHAI) LTD; 600 tian lin rd; shanghai ; CH
• MDR Report Key: 10279604
• Report Number: 2124215-2020-12468
• Device Sequence Number: 11394620
• Product Code: LWS
• UDI-Device Identifier: 00802526570209
• UDI-Public: 00802526570209
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2020

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: 5107863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 10/25/2020
• Patient Sequence Number: 1
• Patient Age: 70 YR