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

Model Number	86641
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
During a procedure involving a lspro ii ep recording system, all the lspro elements shut down.The issue was unable to be resolved and the procedure was cancelled.No patient complications were reported.
Event or Problem Description
During a procedure involving a lspro ii ep recording system, all the lspro elements shut down.The issue was unable to be resolved and the procedure was cancelled.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at boston scientific's post market laboratory the clearsign amplifier visually had a large dent in the top cover of the device, and there was heavy staining on the sides of the outer cover.Functional testing revealed the machine presented with blown fuses and it would not power on.The fuses were replaced and the machine still would not power on.Further testing showed the power supply was at fault.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• 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): EP TECHNOLOGIES, INC.; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12657184
• Report Number: 2134265-2021-13093
• Device Sequence Number: 13754652
• Product Code: DQK
• UDI-Device Identifier: 08714729935902
• UDI-Public: 08714729935902
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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: 86641
• Device Catalogue Number: 86641
• Device Lot Number: 0003035823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown