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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/19/2025
Type of Reportable Event	Serious Injury
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 complaint has been assessed based on the provided information.The customer reported that, following the successful completion of a scan, as the patient was being removed from the scanner, they voluntarily lifted their left leg/knee, causing it to strike the mylar cover of the gantry.This resulted in damage to the cover and a knee laceration that necessitated two sutures for the patient.The customer confirmed that the patient was appropriately restrained using patient straps.The clinical assessment has determined that the required medical intervention (sutures) meets the criteria for a serious injury.However, it is important to note that the injury was a result of the patient's voluntary movement.The incident was not caused by the device or any improper or unintended use of it.Despite this, upon reviewing all available information, this event has been voluntarily determined to be a reportable event.
Additional Manufacturer Narrative
The customer reported that, following the successful completion of a scan, as the patient was being removed from the scanner, they voluntarily lifted their left leg/knee, causing it to strike the mylar cover of the gantry.This resulted in damage to the cover and a knee laceration that necessitated two sutures for the patient.The customer confirmed that the patient was appropriately restrained using patient straps but managed to raise the knee because the patient was in altered mental state (ams) and did not know what was going on.The clinical assessment has determined that the required medical intervention (sutures) meets the criteria for a serious injury.However, it is important to note that the injury was a result of the patient's voluntary movement.The incident was not caused by the device or any improper or unintended use of it.Following the incident, a philips field service engineer (fse) visited the site and replaced the damaged mylar ring on the gantry.After the service work was completed, the system was restored to its normal working condition.
Event or Problem Description
The complaint has been assessed based on the provided information.The customer reported that, following the successful completion of a scan, as the patient was being removed from the scanner, they voluntarily lifted their left leg/knee, causing it to strike the mylar cover of the gantry.This resulted in damage to the cover and a knee laceration that necessitated two sutures for the patient.The customer confirmed that the patient was appropriately restrained using patient straps.The clinical assessment has determined that the required medical intervention (sutures) meets the criteria for a serious injury.However, it is important to note that the injury was a result of the patient's voluntary movement.The incident was not caused by the device or any improper or unintended use of it.Despite this, upon reviewing all available information, this event has been voluntarily determined to be a reportable event.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: 21230750
• Report Number: 3009529630-2025-000001
• Device Sequence Number: 7577857
• Product Code: JAK
• UDI-Device Identifier: 00884838105508
• UDI-Public: (01)00884838105508
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: 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): 03/17/2025

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: 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: 01/19/2025
• Supplement Date Received by Manufacturer: 01/19/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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