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

Model Number	03400010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• 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: 16452169
• Report Number: 1000188474-2023-00001
• Device Sequence Number: 17603343
• Product Code: OWB
• UDI-Device Identifier: 05713464000121
• UDI-Public: 05713464000121
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03400010
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2020
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown