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

Model Number	86620
Medical Device Problem Code	Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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
• 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; 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
• Report Number: 2124215-2023-47159
• Device Sequence Number: 7105086
• Product Code: DRQ
• UDI-Device Identifier: 08714729885948
• UDI-Public: 08714729885948
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 1D911712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown