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

Model Number 03400010

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2023

Event Type  malfunction  

Manufacturer Narrative

From photos received from site, we can clearly see that the drive shaft is broken.A new drive shaft has been installed on site, and the parts involved in the event are being transported to nrt for investigation.Once received, the parts will undergo metallurgic analysis to establish the root cause of the event.

Event Description

During an examination of a patient, it was found that a drive shaft in the ide movement of the intelli-c x-ray device had broken.The ide movement that drives the detector into position, moved until it was stopped by the movement end stop.The event did not cause any injury to patient or operator as no one was hit by the unintended movement.

• Brand Name: INTELLI-C
• Type of Device: 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: 16452169
• MDR Text Key: 310448999
• Report Number: 1000188474-2023-00001
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 05713464000121
• UDI-Public: 05713464000121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03400010
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1