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

Model Number	INCISIVE CT
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint has been evaluated based on the information provided; customer reported that during an angio-lower limb exam involving a slightly obese patient, an error has occurred indicating that the ctdivol exceeds the 250mgy limit, and the requested acquisition cannot be performed due to system limitations.Customer adjusted the protocol parameters, specifically decreased the mas and slowing down the rotation time, however, errors persisted.Customer reports that the patient was in ¿urgent and serious condition¿ and ¿the patient was traumatized.Patient was then transferred to a different hospital to complete the exam.The patient is currently hospitalized per doctor¿s instruction.No other clinical information is available at this time.Based on the available information, this issue has been initially determined to be a reportable event.
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).
Additional Manufacturer Narrative
This complaint has been evaluated based on the information provided; customer reported that during an angio-lower limb exam involving a slightly obese patient, an error has occurred indicating that the ctdivol exceeds the 250mgy limit, and the requested acquisition cannot be performed due to system limitations.Customer adjusted the protocol parameters, specifically decreased the mas and slowing down the rotation time, however, errors persisted.Customer reports that the patient was in ¿urgent and serious condition¿ and ¿the patient was traumatized.Patient was then transferred to a different hospital to complete the exam.The distributor (issue submitter) confirmed that the patient was recovered and no longer hospitalized.This report has been investigated by the philips complaint handling team.It is confirmed that this error message is a fail-safe design to avoid unnecessary excessive radiation to the patient.The emea helpdesk escalation manager along with the clinical specialist provided their further explanation about this event.Based on available information, the team concluded that the error message popped up during the exam indicated that there was a limit, which was not an error.Customer should decrease mas or slow the rotation time, however, due to lack of knowledge or due to lack of training, the customer was not able to adapt the parameters.With the available information, it is concluded that the ct system works as designed, there's no malfunction identified in this complaint.To avoid unnecessary excessive radiation to the patient, when the accumulated ctdivol for the planned perfusion or axial scans exceeds 250mgy, ct system will default to pop up warning message to the user before scan.In this complaint, it shows that this mitigation is effective.Besides, if the system pops up message, the user can provide name and password to continue proceeding the scan.Therefore, there was no hazard/hazardous situation identified in this complaint.

• 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: john maga ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 18900490
• Report Number: 3009529630-2024-00004
• Device Sequence Number: 9255703
• Product Code: JAK
• UDI-Device Identifier: 00884838105508
• UDI-Public: 00884838105508
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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: 02/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2022
• 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: Other
• Patient Sex: Unknown