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

Model Number	INGENUITY ELITE 128
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Hepatitis (1897); Laceration(s) (1946)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted to correct a previous submission that was sent in error due to the use of an incorrect cfn/fei number.This submission reflects the accurate information for this event.All applicable details have been verified, and this report should be considered the official submission.The initial submission should be disregarded.Original report submission number: 3003768277-2025-015636.
Event or Problem Description
The customer reported that a technician sustained a minor cut while wiping down the mylar ring cover on an ingenuity ct system.Additional information confirmed that the technician was cleaning blood from the scanner when they sustained a small percutaneous puncture from the broken mylar.It was confirmed that the exposure involved blood positive for hepatitis c.An attempt was made to obtain the technician¿s post-exposure results; however, the information provided was that the results were "positive," without clarification as to whether this referred to the source blood on the mylar ring or the technician¿s own test results.Due to the lack of clarity regarding the test outcome, this event is being reported as a serious injury.
Additional Manufacturer Narrative
The investigation determined that the reference to the hepatitis c¿positive material applied solely to the source patient¿s blood identified on the ct scanner surface and did not pertain to the technician.There is no evidence to indicate that the technician contracted hepatitis c as a result of this incident.The technician continues post-exposure follow-up monitoring and testing in accordance with occupational health and infectious disease guidelines.Based on the available information and additional analysis, this event does not meet the criteria for a serious injury.Further investigation determined that the mylar ring failed at the main bonding point due to repeated removal and reinstallation.This repeated handling during front cover access caused flexing and stress at the bonding joints, resulting in cracking and formation of a sharp edge.There is no evidence of damage from normal operation; however, service records show the mylar ring was removed multiple times in 2025, which likely contributed to the failure.Based on this information, the reportability determination has been updated to not reportable.The codes were updated based on the investigation outcome patient outcome and health impact codes were corrected.

• Brand Name: INGENUITY CT
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: john maga ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 23778729
• Report Number: 3015777306-2025-000011
• Device Sequence Number: 15981942
• Product Code: JAK
• UDI-Device Identifier: 00884838059504
• UDI-Public: (01)00884838059504
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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?: 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): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2016
• 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: Unknown