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	03/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: complaint pr (b)(4).
Event or Problem Description
The issue reported was during a patient procedure, the heat exchanger came loose/detached within the gantry causing damage internally.There was no report of harm.If this issue were to recur where the heat exchanger were to come loose and be expelled through the gantry, there is potential for death or serious injury.Based on the available information, this issue has been determined to be a reportable event.This event is currently under investigation.
Event or Problem Description
The issue reported was during a patient procedure, the heat exchanger came loose/detached within the gantry causing damage internally.There was no report of harm.If this issue were to recur where the heat exchanger were to come loose and be expelled through the gantry, there is potential for death or serious injury.Based on the available information, this issue has been determined to be a reportable event.
Additional Manufacturer Narrative
The issue reported was during a patient procedure, the heat exchanger came loose/detached within the gantry causing damage internally.Patient was then transferred to another ct system to complete the study.There was no harm to a patient, operator or bystander reported.The philips field service engineer (fse) went to the site and evaluated the system.The x-ray tube heat exchanger was found detached from the heat exchanger box which was attached to the spinning rotor.This resulted in a collision of the heat exchanger with internal gantry components.Cooling fluid leaded due to the collision, however, was contained within the gantry covers.A piece of broken cooling fan housing was expelled out of the gantry and fell on the floor, the weight was measured as 45.8g.The system was replaced at the customer site and returned to the customer for clinical use.All available information and failed part were sent to philips engineering for investigation which concluded: the welding of the heat exchanger box was broken.A mechanical analysis indicated a welding quality issue.Furthermore, it was identified that the heat exchanger box supplied (which is supplied by a 2nd tier supplier) utilized an intermittent welding process.Therefore, the probable cause of the issue is insufficient welding process control by the 2nd tier supplier.Internal cross reference: complaint (b)(4).

• 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: beth johnson ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 16672449
• Report Number: 3009529630-2023-00002
• Device Sequence Number: 12106923
• Product Code: JAK
• UDI-Device Identifier: 00884838085015
• UDI-Public: 00884838085015
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 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: 03/30/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 05/17/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Race: Asian