MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	8864
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Complaint, Ill-Defined (2331)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cancelled procedure occurred.An ilab ultrasound imaging system was selected for use.During the procedure it was noted that the unit is not completing start up and not finding acq pc.No patient complications were reported.
Event or Problem Description
It was reported that a cancelled procedure occurred.An ilab polaris multi-modality guidance system was selected for use.During the procedure it was noted that the unit is not completing start up and not finding acq pc.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the product was received in good conditions.The acquisition processor failed to boot up.The functional test and malware scan could not be performed due to defective hardware inside the acquisition processor.

• Brand Name: ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10252334
• Report Number: 2134265-2020-08956
• Device Sequence Number: 2678887
• Product Code: DQK
• UDI-Device Identifier: 08714729946106
• UDI-Public: 08714729946106
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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: 8864
• Device Catalogue Number: 8864
• Device Lot Number: 0000200227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1