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	10/18/2022
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 the communicator showed no lights, and the communicator power cord was emitting sparks.A boston scientific company representative advised not to continue troubleshooting due to sparking of the communicator power cord.The company representative advised to replace the communicator power cord.No adverse patient effects were reported.The communicator remains in service.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory additional information from product investigation indicates that the allegation against the communicator was confirmed.The returned communicator output voltage was out of specification.There was no measurable evidence of electrical overstress in the communicator modem circuitry.The communicator plastic case was removed, and a burnt smoky smell was observed.The communicator behavior was consistent with a high-power electrical overstress event that was attributed to the environment.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the communicator showed no lights, and the communicator power cord was emitting sparks.A boston scientific company representative advised not to continue troubleshooting due to sparking of the communicator power cord.The company representative advised to replace the communicator power cord.No adverse patient effects were reported.The communicator remains 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 20023 3; CH 200233
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15698227
• Report Number: 2124215-2022-44378
• Device Sequence Number: 12165616
• Product Code: LWS
• UDI-Device Identifier: 00802526544224
• UDI-Public: 00802526544224
• 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
• Report Date (Section B): 02/08/2023

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: 6290
• Device Catalogue Number: 6290
• Device Lot Number: 5400699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 02/08/2023
• 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: 88 YR
• Patient Sex: Male