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

Model Number	86623
Medical Device Problem Code	Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.It will not be returned to boston scientific for laboratory analysis since the issue has been resolved and it is currently working properly.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a procedure the labsystem pro pc crashed/froze and no electrocardiogram (ecg) signals visualization was possible.The software was closed and restarted to resolve the issue.A philips vital monitor was available for spo2 and hearth rate vitals.The procedure was successfully completed without any patient complications.The device is currently working and is not expected to be returned for analysis.

• 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: 14086260
• Report Number: 2134265-2022-04297
• Device Sequence Number: 16681312
• Product Code: DQK
• UDI-Device Identifier: 08714729935872
• UDI-Public: 08714729935872
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2022

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: 0003045141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown