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	04/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the product analysis indicates that the communicator power adapter allegation was not confirmed.Product analysis indicates that the communicator power adapter was supplying power to a communicator over several minutes during the product testing.There was no physical damage observed on the communicator power adapter.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 communicator power cord was getting hot and emitting a burning smell.The patient also observed that the wall outlet cord flickers power on the communicator.A boston scientific company representative advised the patient to replace the communicator power cord.A return label was sent.No adverse patient effects were reported.The product investigation indicates that the communicator power adapter allegation was not confirmed.The communicator was returned for analysis as the power adapter is supplying power to communicator over several minutes during the baseline checks.There was no physical damage observed on the communicator and power adapter.

• 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: 10279599
• Report Number: 2124215-2020-07855
• Device Sequence Number: 2526588
• Product Code: LWS
• UDI-Device Identifier: 00802526570209
• UDI-Public: 00802526570209
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/15/2020

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: 5106902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 07/15/2020
• Patient Sequence Number: 1
• Patient Age: 60 YR