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

Model Number 86623

Device Problems No Display/Image (1183); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2023

Event Type  malfunction  

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 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 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.

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.

• Brand Name: LABSYSTEM PRO EP RECORDING SYSTEM - LSPRO 9900
• Type of Device: 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
• MDR Text Key: 327503861
• Report Number: 2124215-2023-60396
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 08714729935872
• UDI-Public: 08714729935872
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

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
• Device Operator: Health Professional
• Device Model Number: 86623
• Device Catalogue Number: 86623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1