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

Model Number	6280
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the there were no lights on cell adapter and was hot to touch.No adverse patient effects reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory product investigation indicates that the allegation was confirmed.The returned communicator cellular adapter was unable to be utilized by a functional communicator.No light emitting diode (led) light was present indicating the device was not properly able to utilize the supplied power from the communicator and a hardware anomaly exists within the cellular adapter.
Event or Problem Description
It was reported that the communicator showed a yellow sending wave and the communicator cellular adapter was hot to touch.The communicator cellular adapter also showed no lights.The communicator cellular adapter was returned.No adverse patient effects were reported.Additional information from product investigation indicates that the allegation was confirmed.The returned communicator cellular adapter was unable to be utilized by a functional communicator.No light emitting diode (led) light was present indicating the device was not properly able to utilize the supplied power from the communicator and a hardware anomaly exists within the cellular adapter.

• Brand Name: LATITUDE COMMUNICATOR
• Common Device Name: EXTERNAL COMMUNICATOR
• Manufacturer (Section D): JABIL CIRCUIT (SHANGHAI) LTD; 600 tian lin rd; shanghai ; CH
• MDR Report Key: 12243053
• Report Number: 2124215-2021-18240
• Device Sequence Number: 14664506
• Product Code: LWS
• UDI-Device Identifier: 00802526577307
• UDI-Public: 00802526577307
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 5148192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 11/02/2021
• Patient Sequence Number: 1
• Patient Age: 75 YR