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

Model Number 86623

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 09/13/2021

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

A ls pro recording system was selected for use.During preparation for an ablation procedure, patient id was entered into the system and the patient window was closed.An error message 'you will not be able to use any features that require the amplifier.Contact boston scientific technical support if you need assistance' was observed."cancel" or "ok" was pressed the ls pro application was closed.The workstation was rebooted and the application was relaunched, however, error was not resolved.The amplifier was powered on properly and no errors were observed during the self-test and green flashing "system ok" led was seen.Ethernet cable connection was checked with no issues.The procedure was cancelled at this point.

• Brand Name: LABSYSTEM PRO
• 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: 12605560
• MDR Text Key: 276153188
• Report Number: 2134265-2021-12694
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 08714729935872
• UDI-Public: 08714729935872
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86623
• Device Catalogue Number: 86623
• Device Lot Number: 0001972405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1