MAUDE Adverse Event Report: INTERVENTIONAL WORKSPOT; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number 001000

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

It has been reported to philips that during a cerebral artery aneurysm treatment, the customer noticed a difference between the measurement of the aneurysm size on the 3dra interventional tool and the live x-ray image.No harm to the patient or user was reported.Philips has started an investigation of this complaint.

Manufacturer Narrative

Philips has investigated this complaint.Philips confirmed that the cerebral artery aneurysm treatment procedure was completed successfully and that there was no harm to the patient.The customer reported that the aneurysm size was measured close to 5mm on the 3dra image whereas he believed it should be half of that.Philips inspected the system on site and confirmed that there was no malfunction.Philips collected log files of the system and the images used during the procedure by the customer.Based on the analysis of the log files and the images, philips did not identify a malfunction of the system.Philips performed measurements on the 2d and 3d images provided by the customer and resulted in a measurement of approximately 5 mm.Philips has completed a good faith effort to get further information on the reported incident and how the customer performed the measurement.However, the customer has not responded to the requests.According to the instructions for use (4522 203 53191 - chapter 1.2.Intended use & 4522 203 62471 - chapter 4.5.1 quick measurement) - images created by the viewing application are artificially reconstructed images.Diagnosis or treatment cannot be solely based on these images.All findings, decisions, and diagnoses must be confirmed by the use of conventional (2d) x-ray imaging.- quick measurement is a 2d measurement on a 3d image.You should be aware that this measurement method does not take into account any vessel tortuosity and possible cross section anomalies.To achieve maximum measurement accuracy you must position the 3d image in such a way that the measurement has minimal 2d distortion (foreshortening).Based on the available information, philips has concluded that there was no malfunction of the system and is not able to determine the cause of the reported problem.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INTERVENTIONAL WORKSPOT
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• MDR Report Key: 10526898
• MDR Text Key: 207768375
• Report Number: 3003768277-2020-00058
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00884838085367
• UDI-Public: (01)00884838085367
• Combination Product (y/n): N
• PMA/PMN Number: K181177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 001000
• Device Catalogue Number: 001000
• Device Lot Number: 1.4.5.10007
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 90