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

Model Number	INCISIVE CT
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Note: we have not completed our investigation of this event.We will file a follow-up emdr at the complete of the investigation.Internal cross reference: complaint: (b)(4).
Event or Problem Description
This complaint has been evaluated based on the information provided; the issue reported was that a patient who sustained a laceration on the leg after it became trapped between the table and the gantry while the table was being moved.The patient was sedated and intubated at the time of the incident and was being treated for gi bleeding.Additional information was received at a later time confirmed that the patient had a laceration around 5 inches long and into the muscle.It was unable to be repaired with sutures due to the skin being too delicate.Based on the available information, this device event has been classified as a serious injury.Therefore, this event has been determined to be a reportable event.
Additional Manufacturer Narrative
Philips received a complaint reporting that a patient¿s leg got trapped between the table and the gantry, resulting in an injury.The incident happened when the patient was positioned feet-first on the examination couch (fitted with the philips couch mattress, plus a hospital-provided slicker and hover mat).As the patient was moved into the gantry, the right lower inner leg slipped off the couch¿s foot end (the section entering the gantry first), rubbing against the couch edges and gantry.This resulted in a 5-inch-long laceration that penetrated the muscle.Philips has conducted an investigation into this incident, with the following findings: -no leg straps were used to secure the patient during positioning or scanning, causing the sedated patient¿s leg to slip off the couch.The customer stated they were unaware that leg straps were required for patient immobilization.-given the patient¿s sedated state and fragile skin, the leg rubbing against the couch and gantry led to the laceration.The engineering team reviewed the system design and attempted to replicate the incident in a test bay.However, as the customer used a third-party slicker alongside the philips mattress, and no additional details or photos of these accessories were provided, a full replication of the incident could not be achieved.The engineering team also reviewed the instructions for use (ifu) to verify that sufficient user guidance is provided.Relevant instructions in the ifu are as follows: ¿ the patient straps provide immobilization patient during the examination.¿ insert the slip band of patient strap into slideway to combine the patient strap and patient table together.Then you can use the patient strap to immobilize the patient.Warnings are also provided in ifu: ¿ to ensure patient safety and image quality, use patient straps all the time ¿ make sure that the patient is strapped securely to avoid dangling of the hands.Ensure that the patient is placed securely on the patient table and is not in danger of falling.¿ beware straps may cause potential trip and injuries.Remove the straps or fold the straps when not in use.Based on a review of the investigation findings, the root cause of this incident was determined to be the user¿s failure to apply patient straps.The system design (including gantry and couch) complies with iec standards.

• 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: 23653241
• Report Number: 3009529630-2025-000012
• Device Sequence Number: 17369343
• Product Code: JAK
• UDI-Device Identifier: 00884838085015
• UDI-Public: (01)00884838085015
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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): 01/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: INCISIVE CT
• Device Catalogue Number: 728143
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/14/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown