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

Model Number	6290
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that burning smell was coming from the communicator and it was very hot.The communicator was not functioning.A boston scientific company representative discussed with the patient and opted to replace the entire system.The communicator was deactivated.No adverse patient effects were reported.
Event or Problem Description
It was reported that burning smell was coming from the communicator and it was very hot.The communicator was not functioning.A boston scientific company representative discussed with the patient and opted to replace the entire system.The communicator was deactivated.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory additional information from product investigation indicates that the communicator allegation was confirmed.Product analysis indicates that the communicator attempted to boot up and was able to do so for a short while, then remained in a reboot cycle.The communicator board component had a high energy event and was damaged which caused a fluctuating power in the communicator power jack.If information is provided in the future, a supplemental report will be issued.

• 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: 12243134
• Report Number: 2124215-2021-18288
• Device Sequence Number: 3532394
• Product Code: LWS
• UDI-Device Identifier: 00802526544224
• UDI-Public: 00802526544224
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P910077/S140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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
• Device Catalogue Number: 6290
• Device Lot Number: 5247757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 11/02/2021
• Patient Sequence Number: 1
• Patient Age: 84 YR