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

Model Number	INGENUITY FLEX
Medical Device Problem Codes	Unintended System Motion (1430); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
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: (b)(4).
Event or Problem Description
This complaint has been evaluated based on the information provided.The customer reported that after a patient scanning was completed, the patient couch suddenly dropped while lowering the couch.Philips field service engineer(fse) inspected system and identified that ball bearing and ball screw were defective.Fse had the new ball bearing service kit installed and returned the system to customer for clinical use.Patient was frightened but was not actually harmed.A similar product regarding couch dropping downwards rapidly was recently assessed as potential for serious injury if it were to recur.Based on that assessment, we are considering this event reportable out of abundance of caution.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
The customer, (b)(6), reported that after a patient scanning was completed, the patient couch suddenly dropped while lowering the couch.The system was in clinical use during the event.A philips field service engineer (fse) went onsite to evaluate the reported issue and confirmed the patient was not injured and did not receive any treatment.A system inspection determined that the vertical screw rod of the patient couch was not damaged, the cause of the failure was the long-term wear of the bearing.Fse replaced the bearings service kit, and the system was returned to use in good working order.In conclusion, a ball bearing failure was the root cause of the event.A review of the risk management file indicates the problem 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: INGENUITY 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: estelle hilas ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 17538212
• Report Number: 3009529630-2023-00007
• Device Sequence Number: 6333694
• Product Code: JAK
• UDI-Device Identifier: 00884838059528
• UDI-Public: 00884838059528
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: 160743
• 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
• 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: INGENUITY FLEX
• Device Catalogue Number: 728317
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 08/13/2023
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2015
• 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