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

Model Number	86640
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2134265-2022-03073
• Device Sequence Number: 17409031
• Product Code: DRQ
• UDI-Device Identifier: 08714729883302
• UDI-Public: 08714729883302
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown