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	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the communicator power cord was burning and melted.The patient advocate called that about a month ago or so woke up and smelled something burning.The communicator power plug melted and prongs into the receptacle.The patient advocate had to replace the socket and needed pliers to get it out.The company representative opted to replace the power cord.The communicator remains in service while the power cord will be returned for analysis.No adverse patient effects were reported.
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 power cord was burning and melted.The patient advocate called that about a month ago or so woke up and smelled something burning.The communicator power plug melted and prongs into the receptacle.The patient advocate had to replace the socket and needed pliers to get it out.The company representative opted to replace the power cord.The communicator remains in service while the power cord will be returned for analysis.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that the returned power adapter is no longer functioning.Device had been subject to excess heat induced by the patient's environment, likely a faulty power source.The brick plate that holds the prongs of power adapter had begun to melt and bubble and could no longer hold prongs in place for use.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: 13327509
• Report Number: 2124215-2021-38028
• Device Sequence Number: 13865152
• Product Code: LWS
• UDI-Device Identifier: 00802526544224
• UDI-Public: 00802526544224
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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: 5190136
• 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: 12/02/2021
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 01/22/2022
• Supplement Report FDA Received Date: 05/25/2022
• 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: 78 YR
• Patient Sex: Male