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

Model Number	INCISIVE CT
Medical Device Problem Code	Program or Algorithm Execution Failure (4036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported was 6 patient images were found flipped due to precise recognition error and this record is to address patient#3.The customer reported that a patient was positioned for a ct scan, the precise position recognition function has identified the patient images flipped.The operator recognized the issue and corrected the position manually.The following scans was performed 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.
Event or Problem Description
The customer reported was 6 patient images were found flipped due to precise recognition error and this record is to address patient#3.The customer reported that a patient was positioned for a ct scan, the precise position recognition function has identified the patient images flipped.The operator recognized the issue and corrected the position manually.The following scans was performed 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.

• Brand Name: INCISIVE CT
• Common Device Name: 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: 17918130
• Report Number: 3009529630-2023-00012
• Device Sequence Number: 15121237
• Product Code: JAK
• UDI-Device Identifier: 00884838105508
• UDI-Public: 00884838105508
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K212441
• 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 Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial

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: INCISIVE CT
• Device Catalogue Number: 728144
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 10/12/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1622-2023
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Race: Asian