MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BRILLIANCE AIR 40/64/UCT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 728235

Device Problem Unintended System Motion (1430)

Patient Problems Crushing Injury (1797); Bone Fracture(s) (1870)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

We have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.(b)(4).

Event Description

This complaint has been evaluated based on the information provided.The reported issue was that a third party general electric (ge) field engineer (fe) was working below a philips ct system patient table which suddenly fell down hitting the fe on the lower back.Information provided by third party ge stated that the fe sustained a fracture to l1 vertebrae.No other information is available at this time.This issue is under investigation.Based on the available information, this issue has been determined to be a reportable event.

Event Description

This complaint has been evaluated based on the information provided.The reported issue was that a third party general electric (ge) field engineer (fe) was working below a philips ct system patient table which suddenly fell down hitting the fe on the lower back.Information provided by third party ge stated that the fe sustained a fracture to l1 vertebrae.Based on the available information, this issue has initially been determined to be a reportable event.

Manufacturer Narrative

The reported issue was that a third-party general electric (ge) field service engineer (fse) was working below a philips brilliance 40 ct system patient table which suddenly fell down hitting the ge fse on the lower back.Information provided by third party ge stated that the ge fse sustained a fracture to l1 vertebrae.Information received from the ge engineers concluded the following regarding the event: on (b)(6) 2020, a ge fse was replacing the vertical drive motor and screws on the system.After the replacement was completed, a functional test was performed to test the system which completed successfully.Following the tests, while the ge fse was attaching the covers on the rear part of the patient support at the ground level, the table fell suddenly.As the ge fse was on his knees, he was hit on the back and was pushed to the floor.The patient table stopped its run on the emergency load absorption spring (mechanical shock absorber).However, during downward movement, the entire table weight hit the ge fse.Ge engineers concluded that the shaft key was displaced during the reassembly of the cardanic joint which resulted in the table descending downward.The ge fse sustained a fracture to l1 vertebrae and was treated with a seeds mobilization device for the back.Philips engineering reviewed all the details associated with this event and concluded the following: in this event, the key came out when the coupling was knocking on the shaft.This may occur if the key is initially installed in the coupling keyway and the key is not aligned well with the shaft keyway.Inserting the coupling will make the key blocked by the shaft end and finally after the coupling is inserted to its position, the key will still be outside and will drop onto the base.If the missing part is not recognized during assembly time by service, after the set screw of coupling is tightened onto the shaft, there will be certain friction which can still hold the coupling on the shaft.However, the set screw is designed to prevent axial shift but not to transmit torque.The square key is the one to transmit torque.Based on the engineering analysis, service manual procedure review, sequence described in the key install procedure, if the procedure is followed this will not cause the key drop when insert the coupling.This issue was not caused by parts themselves but by assembly non-compliance.The ball square key was not installed correctly, and the ge fse did not recognize this during installation.The patient support repair and replacement manual includes warning statements or instructions: keep equipment and personnel away from the mechanical action of the scissor-action vertical lift mechanism.The lift mechanism is exposed when the patient support telescoping base covers are removed.Failure to comply may result in equipment damage and/or serious injury and/or death to service personnel.Install the vertical safety support brace whenever personnel are working under the table.Failure to do so may result in personnel injury or death.All work must be carried out in accordance with the technical documentation.Make sure (with a second verification) that all mechanical connections are connected properly before starting the equipment after the installation, or assembly replacement.Probable cause: the ge fse did not follow the repair and replacement manual instructions instruction for proper sequence of tasks.The ge fse failed to conduct all verifications after completion of service.Internal cross reference: complaint pr (b)(4) evaluation performed by ge and provided to philips.Philips engineering reviewed information according to to our service documentation.

• Brand Name: BRILLIANCE AIR 40/64/UCT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• MDR Report Key: 10309144
• MDR Text Key: 199900372
• Report Number: 3015777306-2020-00009
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K033326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 728235
• Device Catalogue Number: 728235
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/17/2020
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other