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

Model Number	M00420020220
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an error message appeared at startup indicating the amplifier was not functioning.Subsequently the procedure was cancelled, and it is unknown if sedation was performed.During preparation for a procedure, a labsystem pro was selected for use.Upon start-up an error displayed indicating the system was configured to use the amplifier, but it was not functioning properly.The amplifier was restarted, and an orange led began blinking.The cables were disconnected and reconnected, and the system was restarted again without resolve.Next the ethernet cable was replaced, and the system was rebooted once more.As the issue could not be resolved, the procedure was cancelled.It is unknown if sedation was performed.The device was repaired on site and will not be returned for analysis.
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.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23311176
• Report Number: 2124215-2025-70846
• Device Sequence Number: 20287190
• Product Code: DRQ
• UDI-Device Identifier: 08714729884897
• UDI-Public: (01)08714729884897(11)250114(10)1F457441
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K152693
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2025

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: 1F457441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/16/2025
• Date Device Manufactured: 01/14/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown