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

Model Number 86620

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 321274869
• Report Number: 2124215-2023-43068
• Device Sequence Number: 1
• Product Code: DRQ
• UDI-Device Identifier: 08714729884897
• UDI-Public: 08714729884897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86620
• Device Catalogue Number: 86620
• Device Lot Number: 1D261371
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1