MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LABSYSTEM PRO; AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL

Model Number 86640

Device Problems Device Displays Incorrect Message (2591); Operating System Becomes Nonfunctional (2996)

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

Event Date 02/23/2022

Event Type  malfunction  

Event Description

It was reported that during an ablation procedure the ls pro workstation was not connecting to the clearsign amplifier.The "not finding amplifier / amp not connecting properly" error message was displayed during the procedure.The power on indicator was illuminated in solid green and the system ok indicator was illuminated blinking amber.Laboratory staff was instructed to check the log files and a voltage problem was listed in the files.The issue was not resolved and the procedure was cancelled.No patient complications were reported.The device has been returned for analysis.

Event Description

It was reported that during an ablation procedure the ls pro workstation was not connecting to the clearsign amplifier.The "not finding amplifier / amp not connecting properly" error message was displayed during the procedure.The power on indicator was illuminated in solid green and the system ok indicator was illuminated blinking amber.Laboratory staff was instructed to check the log files and a voltage problem was listed in the files.The issue was not resolved and the procedure was cancelled.No patient complications were reported.The device has been returned for analysis.

Manufacturer Narrative

The lspro workstation was checked on site.It was confirmed that the system was not connected to the amplifier.A new amplifier was used and functional testing was performed.The system passed all tests and it is ready for use.Visual inspection revealed no issue.The reported clinical observation was confirmed.

• Brand Name: LABSYSTEM PRO
• Type of Device: AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): EP TECHNOLOGIES, INC.; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 13805343
• MDR Text Key: 287585552
• Report Number: 2134265-2022-03073
• Device Sequence Number: 1
• Product Code: DRQ
• UDI-Device Identifier: 08714729883302
• UDI-Public: 08714729883302
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86640
• Device Catalogue Number: 86640
• Device Lot Number: 1A285618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1