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

Model Number	6280
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Boston scientific received information that the patient stated communicator is very hot.The communicator was disconnected and no injuries or damages has been reported.A boston scientific company representative opted to replace the communicator.The communicator was deactivated.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 allegation against the communicator was unconfirmed.The communicator passed all debug tests.Product investigation result also confirmed that a wrong communicator power cord was returned since the power cord returned was for a cellular phone.
Event or Problem Description
It was reported that the patient called as the communicator was very hot and had no lights.The patient was partially blind and has difficulty unplugging the communicator.There were no additional adverse patient effects were reported.The company representative opted to send a new communicator.
Event or Problem Description
It was reported that the patient called as the communicator was very hot and had no lights.The patient was partially blind and has difficulty unplugging the communicator.There were no additional adverse patient effects were reported.The company representative opted to send a new communicator.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that the allegation against the communicator was unconfirmed.The communicator passed all debug tests.Product investigation result also confirmed that a wrong communicator power cord was returned since the power cord returned was for a cellular phone and the communicator's front panel icons indicated the normal operation of the communicator.This supplemental report is being filed to correct the b5: describe event or problem, h3: device evaluation by manufacturer and device not eval by mfr code and h10: additional mfr narrative.

• 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: 8809898
• Report Number: 2124215-2019-10665
• Device Sequence Number: 11282165
• Product Code: LWS
• UDI-Device Identifier: 00802526570209
• UDI-Public: 00802526570209
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2020

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: 5135016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/06/2019; 06/02/2019
• Initial Report FDA Received Date: 07/20/2019
• Supplement Report FDA Received Date: 04/30/2020; 05/06/2020
• Patient Sequence Number: 1
• Patient Age: 81 YR