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	05/19/2023
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 showed no power and was observed to smell smoke.A boston scientific company representative opted to replace the communicator.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 additional information from product investigation indicates that the allegation was not confirmed.Analysis found no evidence of device anomaly outside the bounds of normal medical use.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 power and was observed to smell smoke.A boston scientific company representative opted to replace the communicator.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: 17001229
• Report Number: 2124215-2023-26224
• Device Sequence Number: 20407283
• Product Code: LWS
• UDI-Device Identifier: 00802526570322
• UDI-Public: 00802526570322
• 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: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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: 5031977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 08/02/2023
• 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: 41 YR
• Patient Sex: Male