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

Model Number 86620

Device Problem Operating System Becomes Nonfunctional (2996)

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

Event Date 08/09/2023

Event Type  malfunction  

Event Description

It was reported that during a procedure, a labsystem pro was selected for use.Unit froze during the case.Issue occurred about in the middle of a 3 hour case.Account was pacing from the beginning.Troubleshooting with the account extended timing for pacing from 45 minutes to 60 minutes.Procedure was not able to be completed due to this event.No patient complications occurred.Unit will not be returned since it was repaired.This event is being reported for aborted/cancelled procedure with a patient under sedation.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.

Event Description

This event is being reported for aborted/cancelled procedure with a patient under sedation.It was reported that during a procedure, a labsystem pro was selected for use.Unit froze during the case.Issue occurred about in the middle of a 3 hour case.Account was pacing from the beginning.Troubleshooting with the account extended timing for pacing from 45 minutes to 60 minutes.Procedure was not able to be completed due to this event.No patient complications occurred.Unit will not be returned since it was repaired.

Manufacturer Narrative

Correction h6 evaluation conclusion codes: cause not established > cause traced to component failure.The device was not returned to boston scientific for analysis, however, the labsystem pro was evaluated by a boston scientific field service engineer onsite.Checked cmos battery found voltage at 2.760.Replaced cmos battery voltage on new battery was 3.293 v.Upgraded software to 4.2.Tested unit, system passed all functional tests and is ready for use.Analysis was able to confirm the reported clinical observations.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17670484
• MDR Text Key: 322501927
• Report Number: 2124215-2023-47159
• Device Sequence Number: 1
• Product Code: DRQ
• UDI-Device Identifier: 08714729885948
• UDI-Public: 08714729885948
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• 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: 1D911712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1