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

Model Number	6290
Medical Device Problem Codes	Defective Device (2588); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
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 was dark.And was observed, to have a burned smell.A boston scientific company representative advised, the patient troubleshooting steps.No adverse patient effects were reported.The communicator was no longer in service.
Event or Problem Description
It was reported that the communicator was dark and was observed to have a burned smell.A boston scientific company representative advised the patient troubleshooting steps.No adverse patient effects were reported.The communicator was no longer in service.Additional information from product investigation indicates that the communicator allegation was confirmed.Product analysis showed that a burning smell was observed, and charred marks can be found in the electrical component.The communicator behavior was consistent with a high-power electrical overstress event.The damage observed to communicator has been identified as electrical overstress event damage attributed by the environment.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, product analysis indicates that the communicator allegation was confirmed.Product analysis showed that a burning smell was observed, and charred marks can be found in the electrical component.The communicator behavior was consistent with a high-power electrical overstress event.The damage observed to communicator has been identified as electrical overstress event damage attributed by the environment.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
• Manufacturer Contact: timothy degroot degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17211496
• Report Number: 2124215-2023-33424
• Device Sequence Number: 17757749
• Product Code: LWS
• UDI-Device Identifier: 00802526577451
• UDI-Public: 00802526577451
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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: 5052216
• 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: 06/05/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/26/2023
• 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: 38 YR
• Patient Sex: Male