MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. XPERGUIDE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	XPERGUIDE
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that during a cbct scan the orientation of the xperguide display was upside down.The procedure was aborted, however no harm was reported to philips.The user later identified that the table top was positioned backwards on the table base (the head end at the feet and the feet end at the head).Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to additional information acquired, during a planned vascular procedure (embolization of an aneurysm sac in the peripheral vasculature), the images of the xperguide interventional tool display were displayed upside down.The procedure was aborted, and the patient was returned to the hospital ward.The procedure could be rescheduled and completed at a later date.A philips field service engineer (fse) inspected the system onsite and found that maquet tabletop was turned 180 degrees with respect to the table base, causing the xperguide interventional tool to display the images upside down.The tabletop was re-oriented and the system was returned to use in good working order.At the time this complaint was received, philips did not have enough information to exclude a product malfunction with the potential for death or serious injury on recurrence, and as such the complaint was reported.Since that time, new information has been received which has led to the determination that the reported issue is not likely to result in a hazardous situation that could cause or contribute to a serious injury or death.Interventional tools extend the functionality of compatible x-ray equipment with 3d imaging during an interventional procedure.All the interventional tools (suite of software products) run on the platform called interventional workspot (iws) and are intended to be used with a philips interventional x-ray system.Users may be unable to utilize imaging data on the interventional workspot; however, the x-ray imaging data is still available on the x-ray system.Per the system's instructions for use (ifu) : ¿images created by the viewing application (interventional tools) are artificially reconstructed images.Diagnosis or treatment cannot be solely based on these images.All findings, decisions, and diagnoses must be confirmed using conventional (2d) x-ray imaging.¿ hence, users should not merely rely on interventional tools to complete the procedures but confirm with 2d imaging.When the imaging data cannot be utilized on the interventional worskpot, the clinician may decide to postpone the procedure or stop the procedure based on their clinical judgement.This decision is based on the clinician¿s knowledge of the patient¿s status and understanding that the system is still available using 2d imaging.Therefore, the unavailability of an interventional tool is not likely to cause or contribute to a serious injury or death.This complaint has been re-evaluated as non reportable.Global decision tree was updated to no based on the investigation outcome.The codes were updated based on the investigation outcome.
Event or Problem Description
It was reported to philips that during a cbct scan the orientation of the xperguide display was upside down.The procedure was aborted, however no harm was reported to philips.The user later identified that the table top was positioned backwards on the table base (the head end at the feet and the feet end at the head).
Additional Manufacturer Narrative
Philips has investigated this complaint.According to additional information, during a planned vascular cbct (cone-beam computed tomography) scan, the orientation of the xperguide display was upside down.The procedure had already started (the patient was under anesthesia) but was aborted due to the issue.A philips field service engineer inspected the system onsite and confirmed the reported behavior.As part of troubleshooting, the system was checked and found that the table top was positioned upside down on the maquet table base so that the head end of the table top was next to the foot end of the table base.The maquet table base was rotated 180 degrees relative to the table top.Although pivoting the table base and mounting the table top in a reversed way are features of the table, it is not supported by interventional workstation (iw).When the table is positioned like this, then the projections (apc angles) in xperguide are calculated incorrectly.After returning the table the right way on the pedestal, the device returned to use in good working order.The codes were updated based on the investigation outcome.

• Brand Name: XPERGUIDE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16784718
• Report Number: 3003768277-2023-02446
• Device Sequence Number: 14873621
• Product Code: OWB
• UDI-Device Identifier: 00884838059252
• UDI-Public: 00884838059252
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K131263
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: XPERGUIDE
• Device Catalogue Number: 001006
• Device Lot Number: (10)1.3.5
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 10/04/2023; 10/04/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 12/10/2023; 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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