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

Model Number 6290

Device Problem Energy Output Problem (1431)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the communicator was fried, and power supply melted.The patient stated that they had numerous storms recently.The communicator was deactivated.No adverse patient effects were reported.

• Brand Name: LATITUDE COMMUNICATOR
• Type of Device: 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 ; CH
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11220857
• MDR Text Key: 241237573
• Report Number: 2124215-2021-01495
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526585609
• UDI-Public: 00802526585609
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910077/S140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6290
• Device Catalogue Number: 6290
• Device Lot Number: 5432163
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR