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

Model Number	INGENUITY ELITE 128 (728323)
Medical Device Problem Codes	Lack of Maintenance Documentation or Guidelines (2971); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fasciitis (2375)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Reporting determination: this complaint has been evaluated based on the information provided; there is an allegation of serious injury.This issue reported was a field service engineer injured his back during replacement of the x-ray tube.Fse was diagnosed with lumbar fascitis and flurbiprofen was prescribed and rest for a week.Fse was recovered and has been returned to work.Based on the available information, this issue has been initially determined to be a reportable event.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 pr# (b)(4).
Additional Manufacturer Narrative
This issue reported was a field service engineer injured his back during replacement of the x-ray tube.Fse was diagnosed with lumbar fasciitis and flurbiprofen was prescribed and rest for a week.Fse was recovered and has been returned to work.Upon checking the dhf(design history file) and srs(system requirement specification), philips engineering investigation concluded that there is no direct force requirement for pulling up the mrc880 tube toolbox, nor direct requirement on how many persons to replace the x-ray tube.Therefore, the correlative requirement was not included in the tube replacement service manual as well.However, in the service safety manual, it is described that service personnel who performing the service activities on the ct systems are expected to follow the safety manuals which have included safety precautions of taking/lifting heavy components: ¿ always wear proper clothing (e.G.Safety boots and gloves) when handling heavy or awkward loads.Make sure the correct lifting methods are used to avoid physical injury.Follow all procedures carefully and use mechanical devices or multiple fses to handle extremely heavy or awkward loads (>50 lbs/22 kg).Based on these information, the causes of the issue were that service engineer failed to follow the heavy parts replacement instruction provided in the safety manual, also, there's no detailed requirement in the tube replacement manual on how xray tube should be properly handled in case of back injury.Health and safety team has provided training of preventing back injury to fse through philips online training course from preventing issue recurrence.Internal cross reference: complaint (b)(4).
Event or Problem Description
Reporting determination: this complaint has been evaluated based on the information provided; there is an allegation of serious injury.This issue reported was a field service engineer injured his back during replacement of the x-ray tube.Fse was diagnosed with lumbar fasciitis and flurbiprofen was prescribed and rest for a week.Fse was recovered and has been returned to work.Based on the available information, this issue has been initially determined 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: beth johnson ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 17439160
• Report Number: 3009529630-2023-00006
• Device Sequence Number: 19510591
• Product Code: JAK
• UDI-Device Identifier: 00884838059504
• UDI-Public: 00884838059504
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: INGENUITY ELITE 128 (728323)
• Device Catalogue Number: 728323
• 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: 08/01/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male