MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LABSYSTEM PRO; amplifier and signal conditioner, transducer signal

Model Number	M00420020220
Medical Device Problem Codes	Communication or Transmission Problem (2896); Device Sensing Problem (2917); Reset Problem (3019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that all electrocardiogram (ecg) leads were lost in the middle of the case.The error message "before continuing you must reset the amplifier" was displayed, and the amplifier could not be reconnected to the system.Subsequently, the procedure was cancelled.The patient was under general anesthesia.During a procedure, a labsystem pro clearsign ii amplifier was selected for use.In the middle of the case, it was noted that all ecg leads were lost.The error message "before continuing you must reset the amplifier" was displayed.Troubleshooting was performed; the cable was replaced, the amplifier was shut down and was disconnected from the power cord.An attempt was also made to reprogram network interface card 1 (nic1) on the workstation to restore connection to the amplifier; however, the problem was not resolved.The amplifier could not be reconnected to the system.Subsequently, the procedure was cancelled, with part of the procedure completed when the physician decided to discontinue the procedure before its completion.No patient complications were reported.The problem was subsequently resolved following the intervention of a field service engineer.Based on the available information, it appears that the repair was performed directly on the faulty amplifier.

• 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): Boston Scientific Corporation; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 25803464
• Report Number: 2124215-2026-37399
• Device Sequence Number: 8999411
• Product Code: DRQ
• UDI-Device Identifier: 08714729884897
• UDI-Public: (01)08714729884897(11)210820(10)1D910684
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K152693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: M00420020220
• Device Catalogue Number: M00420020220
• Device Lot Number: 1D910684
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/21/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown