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

Model Number	6280
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the communicator and power cord melted, stripped, and blew up because of a lightning storm.A boston scientific company representative reported that no physical injury nor medical treatment was needed.The patient also reported several damaged electronics and heard a big boom in the house.The company representative advised to replace the communicator.The communicator was no longer in service.No adverse patient effects were reported.

• Brand Name: LATITUDE COMMUNICATOR
• Common Device Name: ACCESSORY
• Manufacturer (Section D): JABIL CIRCUIT (SHANGHAI) LTD; 600 tian lin rd; shanghai ; CH
• MDR Report Key: 9592704
• Report Number: 2124215-2019-20211
• Device Sequence Number: 491714
• Product Code: LWS
• UDI-Device Identifier: 00802526570209
• UDI-Public: 00802526570209
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P910077/S140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/15/2020

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: 5125031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 01/15/2020
• Patient Sequence Number: 1
• Patient Age: 80 YR