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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE (SUZHOU) CO., LTD. INCISIVE CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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PHILIPS HEALTHCARE (SUZHOU) CO., LTD. INCISIVE CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Model Number INCISIVE CT
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2023
Event Type  malfunction  
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 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 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.
 
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).
 
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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
beth johnson
100 park avenue, suite 300
orange village, OH 44122
MDR Report Key16672449
MDR Text Key312607406
Report Number3009529630-2023-00002
Device Sequence Number1
Product Code JAK
UDI-Device Identifier00884838085015
UDI-Public00884838085015
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K180015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
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
Date FDA Received04/04/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberINCISIVE CT
Device Catalogue Number728143
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/30/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient RaceAsian
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