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

Model Number INCISIVE CT

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2024

Event Type  Injury  

Event 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.

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).

• Brand Name: INCISIVE CT
• Type of Device: 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: 18900490
• MDR Text Key: 337618179
• Report Number: 3009529630-2024-00004
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00884838105508
• UDI-Public: 00884838105508
• Combination Product (y/n): N
• Reporter Country Code: TS
• PMA/PMN Number: K212441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: INCISIVE CT
• Device Catalogue Number: 728144
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other