MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LABSYSTEM PRO EP RECORDING SYSTEM - LSPRO 9900; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	M00420020340
Medical Device Problem Codes	No Display/Image (1183); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a procedure using an labsystem pro ep recording system - lspro 9900 computer the screen had no display.The procedure took place on (b)(6) 2023 and was cancelled due to this issue.There were no patient complications.Field service was performed on the system on (b)(6) 2023 and it was found the cord to the display monitor was loosely connected.The cable was reconnected, and the display functioned as expected.The system then passed all testing.The system is not expected to be returned as there was no issue found and the site will retain it for use.This event is being reported for aborted/cancelled procedure with a patient under sedation.
Event or Problem Description
It was reported that during a procedure using an labsystem pro ep recording system - lspro 9900 computer the screen had no display.The procedure took place on (b)(6) 2023 and was cancelled due to this issue.There were no patient complications.Field service was performed on the system on (b)(6) 2023 and it was found the cord to the display monitor was loosely connected.The cable was reconnected, and the display functioned as expected.The system then passed all testing.The system is not expected to be returned as there was no issue found and the site will retain it for use.
Additional Manufacturer Narrative
The device was not returned for analysis; however, a field service engineer visited the device on site to perform maintenance.Investigation of this field service report confirmed the allegation in the complaint as the engineer found a loose video cable.The cause was traced to component failure, as disconnecting and reconnecting the cable resolved the issue.
Additional Manufacturer Narrative
This report is being filed to correct the model number in response to an fda request.Because the lot number is unknown, we are unable to provide the unique identifier (udi) # or the device manufacture date.However, we have provided the device identifier (di) portion of the unique identifier (udi) #.The device was not returned for analysis; however, a field service engineer visited the device on site to perform maintenance.Investigation of this field service report confirmed the allegation in the complaint as the engineer found a loose video cable.The cause was traced to component failure, as disconnecting and reconnecting the cable resolved the issue.
Event or Problem Description
It was reported that during a procedure using an labsystem pro ep recording system - lspro 9900 computer the screen had no display.The procedure took place on (b)(6) 2023 and was cancelled due to this issue.There were no patient complications.Field service was performed on the system on (b)(6) 2023 and it was found the cord to the display monitor was loosely connected.The cable was reconnected, and the display functioned as expected.The system then passed all testing.The system is not expected to be returned as there was no issue found and the site will retain it for use.

• Brand Name: LABSYSTEM PRO EP RECORDING SYSTEM - LSPRO 9900
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18047661
• Report Number: 2124215-2023-60396
• Device Sequence Number: 20852456
• Product Code: DQK
• UDI-Device Identifier: 08714729935872
• UDI-Public: 08714729935872
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2024

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: Health Professional
• Device Model Number: M00420020340
• Device Catalogue Number: M00420020340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 11/08/2023; 06/12/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 11/27/2023; 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown