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

Model Number M00420020810

Device Problems Use of Device Problem (1670); Communication or Transmission Problem (2896)

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

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that during a procedure using the ls pro recording system the was not correctly measuring the blood pressure of the patient.At the start of the procedures the blood pressure was normal and then during the procedure the blood pressure would become underestimated.When they checked the calibrated zero was not correct and was lower than expected and needed to be reset.Once the reset has been performed the procedures were completed successfully.During these procedures there were no other systems in use to monitor the vital signs of the patient.The recording system is not expected to be returned as it is going to be repaired on site.

• Brand Name: LABSYSTEM PRO EP RECORDING SYSTEM
• Type of Device: 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: 14553560
• MDR Text Key: 293067089
• Report Number: 2134265-2022-06205
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 08714729996934
• UDI-Public: 08714729996934
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K141185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00420020810
• Device Catalogue Number: M00420020810
• Device Lot Number: 0003148523
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1