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	03/30/2024
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
This complaint has been evaluated based on the information provided; it was reported that t202 , the transformer was loose and fell down into the gantry while device was in use with patient on couch.The gantry mylar ring, gantry cover and cables were damaged as the result of this event.There was no report of injury or harm.Based on the available information, this issue has been initially determined to be a reportable event.Philips has started the investigation of this event.
Additional Manufacturer Narrative
The issue reported was that t202 , the transformer was loose and fell down into the gantry while device was in use with patient on couch.The philips field service engineer (fse) performed an onsite investigation for this issue, it was found that the isolation transformer (t202) on the rotor detached from its mounting location during gantry rotation, and the incisive ct system got slightly damaged.No part expelled outside of the gantry cover.The defective parts were replaced by the fse and the defective transformer was returned for analysis, the system was returned to clinical use after the defective parts replacement.Based on the engineering analysis , the materials of the gantry structure can sustain the collision force from the detached transformer and the failed part, or any other internal gantry component is not expected to be expelled out of the gantry (either toward the outer direction or toward the scanner bore).Therefore, patients/operators/bystanders are not expected to be exposed to the risk of an expelled part.Similarly, service engineers are not expected to be exposed to the risk of an expelled part during repair/maintenance activities with gantry cover closed.Based on the investigation performed, this event is considered a non-reportable event.The system did not cause or contribute to a death or serious injury and would not cause a death or serious injury if this event were to recur.

• 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: 19069009
• Report Number: 3009529630-2024-00005
• Device Sequence Number: 4631376
• Product Code: JAK
• UDI-Device Identifier: 00884838105508
• UDI-Public: (01)00884838105508
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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

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: 03/30/2024
• Supplement Date Received by Manufacturer: 03/30/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2021
• 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