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

Model Number	BRILLIANCE ICT SP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint has been evaluated based on the information provided.The issue reported was that during routine preventive maintenance (pm) work on a brilliance ict, the philips field service engineer (fse) sustained a compound fracture of the left proximal index finger which required surgery.Based on the available information, this issue has been determined to be a reportable event.This event is currently under investigation.
Additional Manufacturer Narrative
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).Date of report: 20211122.Device evaluated by manufacturer? not a device issue.
Additional Manufacturer Narrative
The issue reported was that during routine preventive maintenance (pm) work on a brilliance ict, the philips field service engineer (fse) sustained a compound fracture of the left proximal index finger.The system was not in clinical use when this occurred.The philips field service engineer (fse) was on site performing a routine pm.The injury occurred while doing hand rotation of the ct rotor and cleaning of the brass slip rings with tissues.According to the fse, rotation of the scanner must be performed with the right hand while watching to ensure no damage to any components.While the fse¿s hand was on the slip ring, his glove and finger were caught in the path of the rotor controller receiver as it rotated inside the rotor resulting in damage to the left index finger.After removing his hand from the slip ring, the fse was taken to the emergency room for medical assessment which concluded a compound fracture of the left proximal index finger.The fse underwent surgery, placed in a cast and finger splint, and went through several months of physical therapy.The pm of the ct system was completed by another fse and the system was returned to the customer.The fse stated that he was following the service manual with details of the procedure steps that must be followed for this service activity.The fse also confirmed that he was trained on the brilliance ict product and that the training was provided by philips.Per the brilliance ict/ict sp planned maintenance manual: ¿injury hazard.Use extreme caution when moving the rotating frame by hand.There are many sharp protrusions and close clearance on the rotating frame.Failure to comply may cause serious injury to service personnel.¿ the probable cause was use error: due to lack of caution (as instructed by service manual) the fse¿s hand slipped and was caught in the path of the rotor controller receiver.Internal cross reference: complaint pr# (b)(4).Date of report: 2022-01-04.

• Brand Name: BRILLIANCE ICT
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: beth johnson ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 12851856
• Report Number: 3015777306-2021-10014
• Device Sequence Number: 3992759
• Product Code: JAK
• UDI-Device Identifier: 00884838059481
• UDI-Public: 00884838059481
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: BRILLIANCE ICT SP
• Device Catalogue Number: 728311
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Sex: Male