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

Model Number	86620
Medical Device Problem Code	Power Conditioning Problem (1474)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
During procedure, a clearsign ii amp, 80 channels was selected for use.It was reported that signal interference of body surface was found.The procedure was not completed due to this issue.The patient is stable, no patient complication or other additional intervention reported.Unknown if product is going to be returned.
Event or Problem Description
During procedure, a clearsign ii amp, 80 channels was selected for use.It was reported that signal interference of body surface was found.The procedure was not completed due to this issue.The patient is stable, no patient complication or other additional intervention reported.The console has not been returned for analysis.
Additional Manufacturer Narrative
Product was not returned but was analyzed on site.Based on the work order, the interference was caused by the loose head of the body surface cable.Replaced a set of body surface cable and the fault was resolved.H3 other text : device was analyzed on site.

• 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17175427
• Report Number: 2124215-2023-27107
• Device Sequence Number: 17414830
• Product Code: DRQ
• UDI-Device Identifier: 08714729884897
• UDI-Public: 08714729884897
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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: 86620
• Device Catalogue Number: 86620
• Device Lot Number: 1D904535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown