MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. STENTBOOST LIVE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	STENTBOOST LIVE
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported to philips that when the customer was using stentboost live during a coronary procedure, the information of a previous patient was shown instead of the current patient.A reboot of the azurion system resolved the issue.No harm to the patient has been reported.Philips has started an investigation of this complaint.This complaint is reported as the issue reported relates to medical device correction 2021-igt-bst-027.
Additional Manufacturer Narrative
Add.Narrative: stentboost live is a software medical device that enhances visualization of stents in coronary vessels.It supports the physician in placing and deploying stents and is used in combination with a philips interventional x-ray system.Due to a software defect, the philips stentboost live r2.0 might not process x-ray images for the current run but instead show an image processed in a previous run.The image shown could be from the same patient but it could also be from another patient.The correct patient data is shown on the azurion system.Philips initiated a medical device correction (2021-igt-bst-027).On march 15, 2022, the philips service engineer implemented a software update to correct the system.

• Brand Name: STENTBOOST LIVE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; best 5684 -PC ; NL 5684 PC
• MDR Report Key: 13720680
• Report Number: 3003768277-2022-00104
• Device Sequence Number: 4807409
• Product Code: OWB
• UDI-Device Identifier: 00884838101890
• UDI-Public: 00884838101890
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup

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: STENTBOOST LIVE
• Device Catalogue Number: 001017
• Device Lot Number: (10)2.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown