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

Model Number	6280
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this patient had a remote monitor transmission today; however, on two different occasions, there was no alert transmissions following the anti-tachycardia pacing (atp) episodes.Technical services (ts) asked clinician if the patient had been away from their communicator during this time.The clinician will call the patient to investigate further.No adverse patient effects were reported.The communicator remains in service.
Event or Problem Description
It was reported that this patient had a remote monitor transmission today; however, on two different occasions, there was no alert transmissions following the anti-tachycardia pacing (atp) episodes.Technical services (ts) asked clinician if the patient had been away from their communicator during this time.The clinician will call the patient to investigate further.No adverse patient effects were reported.The communicator remains in service.
Additional Manufacturer Narrative
H6 device codes:device alarm system a1601 - removed (no red alerts).
Additional Manufacturer Narrative
H6 patient codes: patient code - no clinical signs, symptoms or conditions.H6 device codes: device alarm system a1601 - removed (no red alerts).
Event or Problem Description
It was reported that this patient had a remote monitor transmission today; however, on two different occasions, there was no alert transmissions following the anti-tachycardia pacing (atp) episodes.Technical services (ts) asked clinician if the patient had been away from their communicator during this time.The clinician will call the patient to investigate further.Multiple attempts were made to acquire clarifying information about the patient's proximity during the timeframe discussed, to no avail.Remote monitor records indicate the device and communicator are working without incident.No adverse patient effects were reported.The communicator remains in service.

• Brand Name: LATITUDE COMMUNICATOR
• Common Device Name: 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: 12716705
• Report Number: 2124215-2021-32018
• Device Sequence Number: 11873271
• Product Code: LWS
• UDI-Device Identifier: 00802526570209
• UDI-Public: 00802526570209
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2022

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: 6280
• Device Catalogue Number: 6280
• Device Lot Number: 5136244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 11/23/2021; 05/04/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 01/28/2022; 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Male