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

Model Number 86640

Device Problem Failure to Power Up (1476)

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

Event Date 12/09/2022

Event Type  malfunction  

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 Description

The labsystem pro clearsign ii amplifier was selected for use during a procedure.It was reported that the amplifier had power issues with turning on.The cable was swapped, and they confirmed the power source was stable, however, the unit would only turn on once out of the five attempts.No patient complications were reported.The procedure had to be cancelled.It is unknown if the device will be returned for analysis.

Event Description

The labsystem pro clearsign ii amplifier was selected for use during a procedure.It was reported that the amplifier had power issues with turning on.The cable was swapped, and they confirmed the power source was stable, however, the unit would only turn on once out of the five attempts.No patient complications were reported.The procedure had to be cancelled.The device was returned for analysis.

Manufacturer Narrative

The labsystem pro clearsign ii amplifier was returned to boston scientific for analysis.Visual inspection did not show anything noticeably wrong with the unit itself.However, the amplifier failed functional testing for amber light on startup.The fan connected to the power supply was drawing a large power output and required replacement.Therefore, the cause of the reported issue, amplifier appears to turn on 1 out of 5 times, was traced to component failure.The evidence from the product record review did not identify a potential product quality issue or new patient harm.Risk review was completed and confirmed that the event of "clearsign amplifier failure to power-up" was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.

• Brand Name: LABSYSTEM PRO
• Type of Device: 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: 15997341
• MDR Text Key: 305629667
• Report Number: 2124215-2022-53117
• Device Sequence Number: 1
• Product Code: DRQ
• UDI-Device Identifier: 08714729885924
• UDI-Public: 08714729885924
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86640
• Device Catalogue Number: 86640
• Device Lot Number: 1D558442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1