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

Model Number	M00420020230
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction

• 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 -579
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50077371
• Report Number: 2124215-2026-40781
• Device Sequence Number: 10219495
• Product Code: DRQ
• UDI-Device Identifier: 08714729884941
• UDI-Public: (01)08714729884941(11)240916(10)1F113082
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 10/02/2026

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: M00420020230
• Device Catalogue Number: M00420020230
• Device Lot Number: 1F113082
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: Not provided; 09/29/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/03/2026; 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown