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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
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 communicator continually reboots, and the communicator power cord had a short.A boston scientific company representative performed troubleshooting with the communicator connection, and the communicator was able to connect and update firmware.The patient had to hold the communicator in her hands and had to carefully place the communicator back down to avoid a reboot.The company representative opted to replace the power cord and cellular adapter.No adverse patient effects were reported.The communicator remains in service.
Event or Problem Description
It was reported that the communicator continually reboots, and the communicator power cord had a short.A boston scientific company representative performed troubleshooting with the communicator connection, and the communicator was able to connect and update firmware.The patient had to hold the communicator in her hands and had to carefully place the communicator back down to avoid a reboot.The company representative opted to replace the power cord and cellular adapter.No adverse patient effects were reported.The communicator remains in service.
Additional Manufacturer Narrative
Adverse event and product problem on b1 field was changed to product problem.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• 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: 17286343
• Report Number: 2124215-2023-35837
• Device Sequence Number: 3022470
• Product Code: LWS
• UDI-Device Identifier: 00802526570209
• UDI-Public: 00802526570209
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 6280
• Device Catalogue Number: 6280
• Device Lot Number: 5037992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female