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

Model Number	INCISIVE CT
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: we have not completed our investigation of this event.Upon completion, we will submit a follow-up emdr report.Internal cross reference: complaint (b)(4).
Event or Problem Description
The customer alleges that during a contrast scanning procedure, a patient became unstable inside the gantry and began kicking.Consequently, both gantry mylar ring and gantry cone were damaged.The incident occurred while the gantry was rotating, fortunately, there were no reports of harm or injury to the patient.Additional information received from the customer confirmed that the patient had a nervous attack, and a patient strap was used to restraint the patient's upper body.Based on the information available, this event was a direct result of the patient's voluntary movements and was not caused by the device itself.Out of an abundance of caution, this incident has been determined to be a reportable event.
Event or Problem Description
The customer alleges that during a contrast scanning procedure, a patient became unstable inside the gantry and began kicking.Consequently, both gantry mylar ring and gantry cone were damaged.The incident occurred while the gantry was rotating, fortunately, there were no reports of harm or injury to the patient.Additional information received from the customer confirmed that the patient had a nervous attack, and a patient strap was used to restraint the patient's upper body.Based on the information available, this event was a direct result of the patient's voluntary movements and was not caused by the device itself.Out of an abundance of caution, this incident has been determined to be a reportable event.Philips has completed the investigation of this complaint.
Additional Manufacturer Narrative
The customer alleges that during a contrast scanning procedure, a patient in their 60s experienced a nervous attack while inside the rotating gantry, resulting in uncontrolled kicking.This caused damage to the gantry mylar ring and gantry cone cover, forcing an interruption to the contrasted portion of the scan (non-contrast scan had been completed).No injuries were reported to the patient.The philips fse (field service engineer) conducted an onsite inspection of the system and discovered that the mylar ring and gantry cone cover were damaged.After replacing these components, the system was restored to full functionality and returned to operational use.The complaint was escalated for technical investigation, and the findings indicate that this was not a product design issue.The patient experienced a nervous attack, leading to uncontrolled kicking, which resulted in damage to the mylar ring and gantry cone cover.Philips had previously provided warning information to the customer in the incisive ct instructions for use (ifu), emphasizing the importance of securing the patient properly to prevent dangling limbs.To ensure patient safety, it is critical to use patient straps consistently.In this case, it is evident that the patient¿s legs were not restrained as per philips¿ requirements.The device was operational after support was provided to the customer.

• 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: 21570163
• Report Number: 3009529630-2025-000004
• Device Sequence Number: 12949663
• Product Code: JAK
• UDI-Device Identifier: 00884838105508
• UDI-Public: (01)00884838105508
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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: 02/17/2025
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Male