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

Model Number INCISIVE CT

Device Problem No Apparent Adverse Event (3189)

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

Event Date 07/25/2023

Event Type  malfunction  

Event Description

The customer reported that images were identified to be flipped, position was changed from hfs to hfp.There was no hardware issue identified.Philips field service engineer (fse) confirmed the issue was identified after surview scan completion.The following scans was performed and labeled with correct patient position/direction.There was no harm reported in this record.However, based on the internal review of the complaint, this one has been identified to be a repeat malfunction of a previous mdr reportable event.Therefore, this event is considered reportable.Philips has completed the investigation of this event.

Manufacturer Narrative

The customer reported that images were identified to be flipped, position was changed from hfs to hfp.There was no hardware issue identified.Philips field service engineer (fse) confirmed the issue was identified after surview scan completion.The following scans was performed and labeled with correct patient position/direction.There was no harm reported in this record.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.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.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: the system does not alert the user when the patient orientation is automatically selected by precise position and is inconsistent with the present protocol.Corrective action: correction and removal has been issued to all the affected devices.

• 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: estelle hilas ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 17917837
• MDR Text Key: 325703169
• Report Number: 3009529630-2023-00009
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00884838105508
• UDI-Public: 00884838105508
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K212441
• 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: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• 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: 728144
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 07/25/2023
• Patient Sequence Number: 1