MAUDE Adverse Event Report: NRT X-RAY A/S GE PRECISION MPI; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 02980000 (XRF 141)

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

After evaluation of all the available information, it is concluded that the event happened due to an operator error.The operator drove the c-arm into a movable floor standing x-ray shield (not part of the precision mpi device).This caused the image intensifier to partly break off its mounting plate.Neither patient nor operator was harmed.The event could have been avoided if the operator had followed the warnings and instructions in the operators manual and removed the floor standing x-ray shield before moving the c-arm.The system has been repaired on site and is in service.The manufacturer evaluation is based on the event description and photos received from site including an evaluation of historic complaint data and trending.We do not find that the device contributed to the event.

Event Description

Operator drove the c-arm into a movable floor standing lead shield stand causing the image intensifier (ii) to become loose.This did not cause the ii to fall but resulted in physical damage to the equipment.Patient or operator was not harmed.

• Brand Name: GE PRECISION MPI
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): NRT X-RAY A/S; birkegaardsvej 16; hasselager, DK-83 81; DA DK-8381
• Manufacturer (Section G): NRT X-RAY A/S; birkegaardsvej 16; hasselager, DK-83 81; DA DK-8381
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, co ; 9625412
• MDR Report Key: 10021294
• MDR Text Key: 201840464
• Report Number: 1000188474-2020-00001
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/04/2020

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
• Device Operator: Health Professional
• Device Model Number: 02980000 (XRF 141)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1