MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number BI-700-00027-120

Device Problems Material Frayed (1262); Mechanical Problem (1384); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Udi not available for this system at time of filing.The medtronic representative inspected the collimator assembly and revealed that the wire cable for the top shutter had slipped off of a pully wheel and had become pinched, and frayed.A replacement collimator was ordered and installed.They tested the equipment.The imaging system then passed the system checkout and was found to be fully functional.The suspect collimator for the imaging system has been received by the manufacturer for evaluation.However, results are not available at this time.

Event Description

A medtronic representative reported, that while outside of a procedure, during annual planned maintenance on the imaging system, they received an error stating "initializing collimator please wait" error.The collimator kept binding and adjusting and it had not resolved the issue.There was no patient present when this issue was identified and there no additional information provided.

Manufacturer Narrative

The collimator for the imaging system was returned to the manufacturer for evaluation.Testing found that the unit failed bench testing and that the motors were grinding on the imaging system.

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer Contact: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7315748
• MDR Text Key: 101577550
• Report Number: 1723170-2018-00807
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2014
• 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