MAUDE Adverse Event Report: PHILIPS HEALTHCARE (SUZHOU) CO., LTD. INCISIVE CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number INCISIVE CT

Device Problems Use of Device Problem (1670); Program or Algorithm Execution Failure (4036)

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

Event Date 12/02/2022

Event Type  malfunction  

Event Description

The issue reported was the preview images for a patient head scan were flipped; face up position to face down.A philips field service engineer (fse) confirmed the flipped/mislabeled images were not initially recognized which resulted in a misdiagnosis.An additional scan was performed during a clinical examination of the patient prior to surgery which identified that the images were flipped/mislabeled on the initial scan.The surgery was performed on the accurate side and correct medical treatment was provided.There is potential for death/serious injury if this issue were to recur, therefore this event is considered reportable.This issue is currently under investigation.

Manufacturer Narrative

Note: we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: complaint (b)(4).

Manufacturer Narrative

The issue reported was the images for a patient head scan were flipped- face up position to face down.A  philips field service engineer (fse) confirmed the flipped images were not initially recognized which resulted in a misdiagnosis.  an additional scan was performed during a clinical examination of the patient prior to surgery which identified that the  images were flipped on the initial scan.  the surgery was performed on the accurate side and correct medical treatment was provided.Philips engineering investigation concluded that the preliminary cause is a software issue where the algorithm may fail if the patient's appearance is blocked/covered by something beyond camera monitor range/capability (e.G., the patient is placed too deep into the bore or covered by sheet, etc.).  additionally, according to the current design, the auto camera detection of patient orientation will overlap the preset protocol.However, the operator may ignore the change of selected patient orientation.In this specific event, the customer had not been trained on the new precise position functionality when this issue occurred.The option was installed on this system for a few days and the application training had not been completed due to covid-19.Consequently, in this case the operator intended to use a preset exam card with default patient orientation, however used the camera automatic detection function.  the user did not recognize the patient orientation had changed which resulted in flipped images.Per the instructions for use manual, the precise position function may be affected by the following conditions: ¿ when the patient is covered by sheet, blanket etc., ¿ when the patient is not completely covered by the ceiling camera view, e.G.Blocked by the gantry or out of camera's fov etc.¿ when the patient is wearing clothes that reflects light, e.G.Plastic-like clothes.¿ when the patient is wearing black clothes.¿ when the patient is wearing thick clothes.¿ when there are other people around the patient.In addition, the patient orientation selected in patient registration page and the selected patient orientation illustration displayed in plan surview page are visible for user before the user confirms the exam protocols to start the scanning process.Users should  follow the guidelines described in the instructions for use (ifu).It is vital that the users are aware of the system instructions and functionality , and to strictly follow all steps described in the ifu to ensure the safe operation of the device.   probable cause: 1.  the system does not alert the user when the patient orientation is automatically selected by precise position and is inconsistent with the present protocol.2.  the user was not trained on the precise position functionality.A corrective action will be implemented which will alert the user patient orientation is automatically selected by precise position and is inconsistent with the present protocol.  internal cross reference: complaint pr# (b)(4).

Event Description

The issue reported was the preview images for a patient head scan were flipped; face up position to face down.A philips field service engineer (fse) confirmed the flipped/mislabeled images were not initially recognized which resulted in a misdiagnosis.An additional scan was performed during a clinical examination of the patient prior to surgery which identified that the images were flipped/mislabeled on the initial scan.The surgery was performed on the accurate side and correct medical treatment was provided.Based on the initial assessment, this issue was determined to be a reportable event.

• Brand Name: INCISIVE CT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS HEALTHCARE (SUZHOU) CO., LTD.; no. 258, zhongyaun road; suzhou industrial park; suzhou jiangsu 21502 4; CH 215024
• Manufacturer (Section G): PHILIPS HEALTHCARE (SUZHOU) CO., LTD.; no. 258, zhongyaun road; suzhou industrial park; suzhou jiangsu 21502 4; CH 215024
• Manufacturer Contact: beth johnson ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 16035044
• MDR Text Key: 308281063
• Report Number: 3009529630-2022-00002
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00884838085015
• UDI-Public: 00884838085015
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K180015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INCISIVE CT
• Device Catalogue Number: 728143
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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