MAUDE Adverse Event Report: NRT X-RAY A/S INTELLI-C, FOOTREST; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	03282000
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event took place at a hospital in (b)(6) but since the device involved is also marketed in the us, we decided to report this to the fda.The footrest from the site is being investigated.From the information available, we can conclude that the friction rubber strip on one side of the footrest compression mechanism fell off before the operator locked the footrest into place on the patient table, as the rubber was found on the floor.The footrest did not fall to the floor as it was held in place by the friction rubber on the opposite side of the patient table which was able to carry the weight of the patient.
Event or Problem Description
It was reported that the footrest slid down along the patient table while in use with a patient.The patient grabbed the patient table and did not fall.

• Brand Name: INTELLI-C, FOOTREST
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): NRT X-RAY A/S; birkegaardsvej 16; hasselager, midtjylland 8361 ; DA 8361
• Manufacturer (Section G): NRT X-RAY A/S; birkegaardsvej 16; hasselager, midtjylland 8361 ; DA 8361
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 13318352
• Report Number: 1000188474-2021-00001
• Device Sequence Number: 20137597
• Product Code: OWB
• UDI-Device Identifier: 05713464000336
• UDI-Public: 05713464000336
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K173631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2021

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: Health Professional
• Device Model Number: 03282000
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown