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

Model Number	6290
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the communicator power cord was getting hot.The communicator was excessively rebooting.There were no storms or power outages reported.A boston scientific company representative opted to replace the communicator.The communicator is no longer in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the communicator power cord was getting hot.The communicator was excessively rebooting.There were no storms or power outages reported.A boston scientific company representative opted to replace the communicator.The communicator was returned for analysis, and the patient received a new communicator.Additional information from the product investigation indicates that the allegation was confirmed.The cause was not established, where it was confirmed that a flash file corruption was attributed to the communicator being locked, with no known root cause.The communicator is no longer in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory product investigation indicated that the allegation was confirmed.The cause was not established, where it was confirmed that a flash file corruption was attributed to the communicator being locked, with no known root cause.
Event or Problem Description
It was reported that the communicator power cord was getting hot.The communicator was excessively rebooting.There were no storms or power outages reported.A boston scientific company representative opted to replace the communicator.Additional information from the product investigation indicates that the allegation was confirmed.The cause was not established, where it was confirmed that a flash file corruption was attributed to the communicator being locked, with no known root cause.The communicator is no longer in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory product investigation indicated that the allegation was confirmed.The cause was not established, where it was confirmed that a flash file corruption was attributed to the communicator being locked, with no known root cause.

• Brand Name: LATITUDE COMMUNICATOR
• Common Device Name: EXTERNAL COMMUNICATOR
• Manufacturer (Section D): JABIL CIRCUIT (SHANGHAI) LTD; 600 tian lin rd; shanghai ; CH
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23838075
• Report Number: 2124215-2025-91662
• Device Sequence Number: 20091658
• Product Code: OSR
• UDI-Device Identifier: 00802526585609
• UDI-Public: (01)00802526585609
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2026

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: 5341124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 02/09/2026; 03/03/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/10/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Male