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

Model Number	INCISIVE CT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
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 pr# (b)(4).
Event or Problem Description
It was reported that the heat exchanger had become detached from its housing, causing damage to other internal components within the gantry.However, the heat exchanger box itself remained intact.There was no report of harm.However, if this issue was to recur, it is uncertain whether it is likely to cause a serious injury.Based on the information currently available, this issue has been determined to be a reportable event.Philips has initiated an investigation of this event.
Additional Manufacturer Narrative
25-jul-2025.A complaint was received on the philips incisive ct system regarding the detachment of a heat exchanger from its housing during a patient scan, resulting in collision with other components.The system was in clinical use at the time, no actual injuries occurred.This complaint has been investigated by the philips complaint handling team, it was identified that a fco¿ incisive ct cooling unit heat exchanger box replacement - extension b ¿ had been executed on this reported system(sn (b)(6)) in nov-2024.Through interviews, we confirmed the field service engineer (fse) did not use a torque wrench to achieve the required 4.5 nm bolt torque during the fco procedure.Over time, this incorrect torque caused the screws to loosen and eventually detach during system operation.To verify this finding, we sent the returned screws along with screws tightened to 4.5nm, 2.3nm, and new unused screws to 3d party lab (lile) for testing (including spring washer height measurement and microscopic examination).The test results showed the returned screws had significantly higher spring washer heights than those properly tightened to 4.5nm, confirming they were not correctly tightened.The flat washer undersurfaces also showed clear differences supporting this conclusion.Therefore, we determined the root cause was the fse's failure to apply the proper torque to the screws during the fco.After the incident, the fse inspected the system onsite, replaced all damaged parts, and restored full system functionality.The system is now operating normally with no further problems.

• 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: 22042148
• Report Number: 3009529630-2025-000010
• Device Sequence Number: 18396719
• Product Code: JAK
• UDI-Device Identifier: 00884838105508
• UDI-Public: (01)00884838105508
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 07/24/2025

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: 04/21/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2023
• 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: Unknown