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

Model Number 8864

Device Problem Computer Operating System Problem (2898)

Patient Problems No Consequences Or Impact To Patient (2199); Complaint, Ill-Defined (2331)

Event Date 06/16/2020

Event Type  malfunction  

Event 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 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.

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
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10252334
• MDR Text Key: 198162146
• Report Number: 2134265-2020-08956
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 08714729946106
• UDI-Public: 08714729946106
• Combination Product (y/n): N
• PMA/PMN Number: K151613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1