MAUDE Adverse Event Report: EP TECHNOLOGIES, INC. LABSYSTEM PRO; AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL

Model Number	86620
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be return for analysis.Upon completion of the failure analysis of the event reported, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
During procedure, an labsystem pro clearsign ii amp, 80 channels was selected for use.It was reported that amplifier and the software could not be turned on.The procedure was not completed due to this event.The patient is stable, no patient complication or other additional intervention reported.The device won't be returned since the issue was solved on site, the software ran normally, and the amplifier was maintained and there are not device components to be returned.This event is being reported for aborted/cancelled procedure with a patient under sedation.
Additional Manufacturer Narrative
Clearsign ii amp was not returned and evaluated by boston scientific, but the on-site service was reviewed during the course of this investigation, the device was tested many times related to the failure reported, and the machine started normally, also the software is running normally.Communication with the costumer was made and the amplifier got maintenance, so the device was tested again, and it started normally.The reported allegation is not confirmed.
Event or Problem Description
During procedure, an labsystem pro clearsign ii amp, 80 channels was selected for use.It was reported that amplifier and the software could not be turned on.The procedure was not completed due to this event.The patient is stable, no patient complication or other additional intervention reported.The device won't be returned since the issue was solved on site, the software ran normally, and the amplifier was maintained and there are not device components to be returned.This event is being reported for aborted/cancelled procedure with a patient under sedation.

• Brand Name: LABSYSTEM PRO
• Common Device Name: AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
• Manufacturer (Section D): EP TECHNOLOGIES, INC.; 150 baytech dr.; san jose CA 95134
• 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: 17558648
• Report Number: 2124215-2023-43068
• Device Sequence Number: 4917518
• Product Code: DRQ
• UDI-Device Identifier: 08714729884897
• UDI-Public: 08714729884897
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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: 1D261371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown