MAUDE Adverse Event Report: FUJIFILM CORPORATION FDR D-EVO SUITE II; FLAT PANEL/DIGITAL IMAGER

Model Number 800021530

Device Problems Mechanical Problem (1384); Retraction Problem (1536); Mechanical Jam (2983)

Patient Problem Skin Tears (2516)

Event Date 01/25/2024

Event Type  Injury  

Manufacturer Narrative

Comp ref #(b)(4).Fuji engineer visited the site and talked with radiology director.The director explained that the patient was a young boy with a broken elbow, accompanied by parent.He was sitting on a chair at the left end of the x-ray table and his arm was laid on the table top, knees under the table top.The student tech was watching next to the table.When the lead tech was adjusting his elbow the boy started screaming louder but everyone thought it was because of the pain on his arm.The table was apparently lowering until it pressed against his legs and stopped.The lead tech and the student tech tried to raise the table to using the foot switch but it would not move up.The lead tech had to use his hands and by force lift the table up enough to release the patient.The patient ended up with scratches on the knee skin but did not bleed.He had x-rays done afterwards but no injury was found.Fuji engineer talked with lead tech, too and he explained on everything.Fuji engineer had checked both emergency switches, both swithced were ok.Checked up/down pressure detection sensor: sensor was ok.Greased all rails and up/down motor for smooth movement.Lubricated floating surfaces/rails and cleaned everything.Checked foot switch buttons, and cables functionality: which was ok.Performed multiple performance tests, all successful.System is working as designed.

Event Description

On january 25th, 2024, fujifilm healthcare americas corporation was informed of an event involving d-evo_suite_ii.It was reported that while the patient was sitting in a chair, the table came down on his leg.The tech had to push it off his leg.There was no report of harm, breaks, or cuts.No additional information was provided.

• Brand Name: FDR D-EVO SUITE II
• Type of Device: FLAT PANEL/DIGITAL IMAGER
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 00258 8538; JA 002588538
• MDR Report Key: 18682123
• MDR Text Key: 335074635
• Report Number: 1000513161-2024-00009
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2024,02/09/2024

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
• Device Operator: Health Professional
• Device Model Number: 800021530
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/25/2024
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other