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

Model Number	INGENUITY ELITE 128
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reporting determination: this complaint has been evaluated based on the information provided.The customer reported system made a very loud noise and then table dropped from raised position for approximately 4 inches when patient got on the table.There was no report of harm.The patient went to a different facility (hospital site) to complete study.Philips field service engineer evaluated the system and confirmed that the ball screw and bearings had failed.The couch was replaced at the customer site. we are considering this event reportable out of abundance of caution.   philips field service engineer evaluated the system and confirmed that the ball screw and bearings had failed.The couch was replaced at the customer site.Philips has started an investigation of this complaint.
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 (b)(4).
Event or Problem Description
Reporting determination: this complaint has been evaluated based on the information provided.The customer reported system made a very loud noise and then table dropped from raised position for approximately 4 inches when patient got on the table.There was no report of harm.The patient went to a different facility (hospital site) to complete study.Philips field service engineer evaluated the system and confirmed that the ball screw and bearings had failed.The couch was replaced at the customer site and device was returned to clinical use after the service.
Additional Manufacturer Narrative
The customer reported that system made a very loud noise and then table dropped from raised position for approximately 4 inches when patient got on the table.There was no report of harm.The patient went to a different facility (hospital site) to complete study.Philips field service engineer evaluated the system and confirmed that the ball screw and bearings had failed.The couch was replaced at the customer site.System was returned to the customer for clinical use after service.Inspection of the failed parts was performed by the sz research and development (r&d), and it was confirmed that the vertical ball screw had fractured.The failed vertical ball screw was further analyzed by the 3rd party laboratory suzhou metal services co, ltd whom confirmed that the ball screw fractured was due to fatigue failure.The ball screw inventory was checked, all the parts meet the drawing spec, therefore, material and supplier quality issue was excluded from failure root cause.Couch manufacturing process for ball screw alignment and installation were checked through tolerance stack up and production couch alignment accuracy measurement.The calculation shows the production alignment can meet the spec.Sampling checked the production couch measurement accuracy were all within spec.Couch manufacturing can be excluded for failure root cause.According to the design analysis, ball screw excessive misalignment was determined to be the root cause of the fatigue.¿ during the site inspection, the upgrade kit was not installed on couch in previous ball screw replacement.Fse was not familiar with alignment solution (alignment procedure, upgrade kit) ¿ according to the service data analysis for the similar complaints, the alignment tool and upgrade kit were missing in service record.Corrections: -released vertical drive replacement tool kit (alignment tool) in spare parts system (sps) to make it available for fse to ensure they can use it during vertical parts replacement process.-updated ingenuity series patient support repair and replacement manual to define using vertical drive replacement tool kit (alignment tool) in section ¿vertical motor and vertical drive extended support bearing retainer alignment procedure and vertical motor and vertical drive standard¿ and section ¿bariatric support bearing retainer alignment procedure¿ to ensure fses use the tool during vertical parts replacement process.-updated trouble shooting manuals and troubleshooting guide to add ball screw inspection details in section mechanically related couch problem.Internal cross reference: (b)(4).

• 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: 16937719
• Report Number: 3009529630-2023-00003
• Device Sequence Number: 7461245
• Product Code: JAK
• UDI-Device Identifier: 00884838059504
• UDI-Public: 00884838059504
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K160743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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: INGENUITY ELITE 128
• Device Catalogue Number: 728323
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2015
• 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
• Patient Race: Asian