MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LABSYSTEM PRO; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	86623
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
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
It was reported that during a procedure using a lspro recording system there were no ecg signals.At the start of the procedure no signals were available.Due to this the procedure was cancelled after the patient had already been sedated.There were no patient complications.The lspro is not expected to be returned as it will be serviced on site.
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.However, a field service engineer examined the device at the site.This engineer performed a function test of the device and found that the observed error was not caused by the device.The computer passed all testing, and no issue could be found with the computer that could have caused or contributed to the issue observed in the field.Investigation concluded that there was no problem detected with the device.
Event or Problem Description
It was reported that during a procedure using a lspro recording system there were no ecg signals.At the start of the procedure no signals were available.Due to this the procedure was cancelled after the patient had already been sedated.There were no patient complications.The lspro is not expected to be returned as it will be serviced on site.

• Brand Name: LABSYSTEM PRO
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: 15432344
• Report Number: 2124215-2022-36243
• Device Sequence Number: 5569928
• Product Code: DQK
• UDI-Device Identifier: 08714729935872
• UDI-Public: 08714729935872
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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: 86623
• Device Catalogue Number: 86623
• Device Lot Number: 0001944714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown