MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. IQON SPECTRAL CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	IQON SPECTRAL CT
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The issue reported was during patient preparation while moving the table up in the vertical direction, the table descended rapidly down and when it reached its lowest point there was a loud noise.A philips field service engineer evaluated the system and found the ballscrew was broken which caused the table to descend.There was no harm to patient or operator and no medical intervention was necessary as a result.We are considering this event reportable out of abundance of caution.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips engineering has not completed the investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: (b)(4).
Additional Manufacturer Narrative
Philips has started an investigation of this complaint.As per the information provided, a philips service engineer inspected the system onsite and confirmed that the reported problem was due to a defective vertical spindle.The entire ball screw assembly was replaced.The investigation is still in process and has not yet been completed.A final report will be sent when the investigation is complete.Cross reference: complaint (b)(4).
Additional Manufacturer Narrative
Note: this investigation is still in process therefore, we have not completed our investigation of this event.A final report will be sent when the investigation is complete.Cross reference: (b)(4).
Additional Manufacturer Narrative
The issue reported was that while moving the table up in the vertical direction for scan preparation, the table descended rapidly approximately 30cm and when it reached its lowest point there was a loud noise.A philips field service engineer (fse) went onsite to evaluate the system and found the table in its lowest (down) position.The system was inspected and the fse confirmed that the reported problem was due to a defective vertical spindle of the ball screw assembly which caused the table to descend.There was no harm to patient or operator and no medical intervention was necessary as a result.The entire ball screw assembly was replaced and no further deviations were found.The system was tested successfully and returned to the customer for use.In a similar incident, a philips fse collected the vertical ball screw and bearing parts and returned them to the suzhou (sz) factory for a failure analysis.Analysis confirmed the vertical ball screw was fractured and a further material analysis was performed by a 3rd party lab (suzhou metal service co.Ltd).According to the analysis, the ball screw failure was caused by a fatigue fracture.In addition to the analysis, ball screw inventory was checked and the parts met drawing specifications.Therefore, a material and supplier quality issue was excluded for failure root cause.Couch manufacturing process for ball screw alignment and installation were also checked through tolerance stack up and production couch alignment accuracy measurement.The calculation determined the production alignment meets specification.Sampling checked the production couch measurement accuracy, and all were within specifications.Therefore, couch manufacturing was excluded for failure root cause.After reviewing all event details, philips engineering confirmed there were no new failure modes.During site inspection, the philips fse found the upgrade kit was not installed on the couch in the previous ball screw replacement and the alignment of the ball screw replacement was not performed per the service manual; the alignment tool was designed to avoid misalignment during ball screw replacement.Additionally, the philips ct system is intended to be used and operated only in accordance with the safety procedures and operating instructions given in the instructions for use for the purpose for which it was designed.Operators of the philips system must have received adequate training on its safe and effective use before attempting to operate the equipment described in the instructions for use.The philips systems should not be used if any of the following conditions exist or are thought to exist.The preventative maintenance program is not up-to-date.If any part of the equipment or system is known (or suspected to be) operating improperly.During all movements of the gantry and the patient table (automatic and manual), keep the patient under continuous observation.Make sure that the patient is strapped securely to avoid dangling of the hands.Ensure that the patient is placed securely on the patient table and is not in danger of falling.In conclusion, the root cause of the ball screw failure was determined to be fatigue due to misalignment from no use or partial use of the ball screw service install kit.A review of the risk management file indicates the issue reported by the customer is of low potential severity, which would not reasonably cause or contribute to death or serious injury if the problem were to reoccur.Therefore, based on the investigation¿s conclusion, this issue has been determined not to be a reportable event.

• Brand Name: IQON SPECTRAL CT
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; high tech campus 36; eindhoven 5656A E; NL 5656AE
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; high tech campus 36; eindhoven 5656A E; NL 5656AE
• Manufacturer Contact: matthew jolliff ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16992227
• Report Number: 3015777306-2023-00013
• Device Sequence Number: 7067475
• Product Code: JAK
• UDI-Device Identifier: 00884838059542
• UDI-Public: 00884838059542
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K193454
• 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,Followup,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: IQON SPECTRAL CT
• Device Catalogue Number: 728332
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/14/2023
• Supplement Date Received by Manufacturer: 05/14/2023; 05/14/2023; 05/14/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 06/21/2023; 07/18/2023; 12/12/2023
• Date Device Manufactured: 08/19/2020
• 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