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

Model Number	6280
Medical Device Problem Codes	Defective Device (2588); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
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 was not able to connect, hot and smelled like smoke.The patient reconnected the communicator but was still the same.The communicator issue was not resolved.A new communicator and a cellular adapter were sent.No adverse patient effects were reported.The communicator was no longer in service.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory product investigation indicates that the issue was confirmed.A resistance measurement was taken for the returned communicator diode showed its output voltage was out of specification.The communicator behavior was consistent with a high-power electrical overstress event.There was no measurable evidence of electrical overstress in the communicator modem circuitry.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 was not able to connect and hot and smelled like smoke.The patient reconnected the communicator but was still the same.The communicator issue was not resolved.A new communicator and a cellular adapter were sent.No adverse patient effects were reported.The communicator was no longer in service.

• Brand Name: LATITUDE COMMUNICATOR
• Common Device Name: EXTERNAL COMMUNICATOR
• Manufacturer (Section D): JABIL CIRCUIT (SHANGHAI) LTD; 600 tian lin rd; shanghai ; CH
• Manufacturer (Section G): JABIL CIRCUIT SHANGHAI LTD; 600 tian lin rd; shanghai, 020 20023 3; CH 200233
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17862464
• Report Number: 2124215-2023-54472
• Device Sequence Number: 6073117
• Product Code: LWS
• UDI-Device Identifier: 00802526577307
• UDI-Public: 00802526577307
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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: 5147453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male