MAUDE Adverse Event Report: NRT - NORDISK RONTGEN TEKNIK A/S PRECISION MPI; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I

Model Number XRF141

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the manufacturers investigation.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2020, the radiographic technologist (rt) at (b)(6) reported that as they were commanding the movement of the positioning c-arm on their precision mpi fluoroscopic system downward, they impacted a moveable glass shield stand which caused the image intensifier to detach from the image intensifier lift assembly.There was a patient present, but they were not impacted when the image intensifier detached.There was no injury related to this event.This product is not manufactured by ge healthcare.Ge healthcare is the importer of the precision mpi system.

Manufacturer Narrative

The manufacturer of the precision mpi system nrt x-ray a/s has completed their investigation and the root cause was determined to be operator error as the operator of the device unintentionally drove the c-arm onto a moveable floor standing x-ray shield.This x-ray shield is not considered to be part of the precision mpi system.The collision caused the image intensifier to detach from the c-arm mounting plate but was held hanging by the image intensifier elevator drive chain.Neither the patient nor operator was harmed.To correct the system, the ge field engineer replaced the image intensifier elevator assembly.In addition, according to the precision mpi operatorâs manual, there are multiple warnings to the operator regarding collisions when commanding the movement of the c-arm.These warning were also reviewed with the operator.No further actions are needed.

• Brand Name: PRECISION MPI
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I
• Manufacturer (Section D): NRT - NORDISK RONTGEN TEKNIK A/S; birkegaardsvej 16; hasselager 8361 ; DA 8361
• MDR Report Key: 9940481
• MDR Text Key: 199081833
• Report Number: 2126677-2020-00003
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K033486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XRF141
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1