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

Model Number	INCISIVE CT
Medical Device Problem Code	Intermittent Program or Algorithm Execution (4035)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.It was reported that patient orientation detected by camera was not correct and incorrect acquisition was made.Issue was identified and a patient rescanned was performed with correct patient position/direction labelled.There was no patient injury or harm reported.However, iia(issue impact assessment) d001255537_rev_c was updated with risk assessment re-evaluated.An internal retrospective review of the complaint has identified this complaint a similar malfunction of a mdr event we have reported.Therefore, this issue has been determined to be a reportable event.Risk evaluation conclusion in iia: poh for s0 ¿ misdiagnosis is estimated at l3 - probable.Poh for s1 ¿ misdiagnosis is estimated at l2 - remote.Poh for s2 ¿ misdiagnosis is estimated at l2 - remote.Poh for s3 ¿ misdiagnosis is estimated at l2 ¿ remote.Philips has completed the investigation of this event.
Additional Manufacturer Narrative
The customer reported that patient orientation detected by camera was not correct and incorrect acquisition was made.Issue was identified and a patient rescanned was performed with correct patient position/direction labelled.There was no patient injury or harm reported.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: system software limitation.Corrective action: correction and removal has been issued to all the affected devices.

• 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: 17993981
• Report Number: 3009529630-2023-00021
• Device Sequence Number: 6726126
• Product Code: JAK
• UDI-Device Identifier: 00884838105508
• UDI-Public: 00884838105508
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: 11/19/2021
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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