MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENUITY CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number INGENUITY CT

Device Problem Patient Data Problem (3197)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

We have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.(b)(4).

Event Description

This complaint has been evaluated based on the information provided.The issue reported was that during a ct guided puncture, newly created ct images were not updated after the message "viewer memory full" was displayed on the console.This resulted in the patient's portal vein was inadvertently punctured.The patient was transferred to another ct system to evaluate potential injury(internal bleeding) as a result of the portal vein puncture.Patient outcome is unknown at this time.Based on the available information, this issue has been determined to be a reportable event.

Manufacturer Narrative

The issue reported was that during a ct guided puncture, newly created ct images were not updated after the message "viewer memory full" was displayed on the console.This resulted in the patient's portal vein being inadvertently punctured.A philips remote service engineer (rse) confirmed with the customer that after a complete spiral examination of the upper abdomen and thorax were scanned, the user began the puncture procedure.While the puncture was being started, a message was displayed on the console that the viewer memory was full.As a result of the viewer memory being full, the newly scanned images were not updated, even though the preview of the new images were displayed, and the evolving images were confirmed by the user.Thus, an old image set was still displayed which resulted in the portal vein being slightly cut.After detecting the perforation of the vein, the user stopped the puncture.The patient was moved to another scanner to evaluate the perforation and no treatment was necessary.A philips application specialist (as) revealed that after the preliminary examination (upper abdomen and thorax), no new examination was started.However, during this examination, the puncture was started and the affected scan to check the position of the needle continued to be used.The as instructed the customer that they should begin a new examination after the preliminary scans have been completed for puncture procedures, in order to start with an empty viewer memory.The philips rse confirmed the viewer memory got flooded due to the customers workflow.The customer didn't start a new study to control the position of the needle but used the current helical scan so there was only a small amount of viewer memory available to display the new images added to the current study.Logfiles were captured by the rse and sent to philips for review.Philips engineering reviewed all available information and determined that the system was last restarted on (b)(6) 2020.This event occurred on (b)(6) 2020 and there was no restart of the system observed in-between this time frame.Review of the logfiles for the time of the event confirmed that all cct scans had been successfully reconstructed.Conclusion of the event details was that the ct system had not been restarted for many days which lead to scarcity of system resources.Per the ingenuity ct scanner instructions for use manual: the following is recommended to keep your scanner running efficiently: maintain the local disk at or below 75% capacity (approximately 400 studies).After finishing use of an application, close or exit the application.Perform a host computer restart daily, this will refresh the host computer.Startup/shutdown of the entire system should be done once a week.Probable cause: there was no malfunction of the device.The system memory being full was caused by the system not being restarted, as per philips recommendations.This event is not reportable.

Event Description

This complaint has been evaluated based on the information provided.The issue reported was that during a ct guided puncture, newly created ct images were not updated after the message "viewer memory full" was displayed on the console.This resulted in the patient's portal vein was inadvertently punctured.The patient was transferred to another ct system to evaluate potential injury(internal bleeding) as a result of the portal vein puncture.Patient outcome is unknown at this time.Based on the available information, this issue has been determined to be a reportable event.

• Brand Name: INGENUITY CT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• MDR Report Key: 10399367
• MDR Text Key: 202989100
• Report Number: 3015777306-2020-00010
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00884838059511
• UDI-Public: 00884838059511
• Combination Product (y/n): N
• PMA/PMN Number: K160743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INGENUITY CT
• Device Catalogue Number: 728326
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/06/2020
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1