MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M

Model Number BI70000028230

Device Problems Imprecision (1307); Wireless Communication Problem (3283)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved when the reported issue occurred.A medtronic representative went to the site to test the equipment.Testing revealed that the right side trackers were found to be out of calibration.A re-calibration was performed and functionality was restored.The imaging system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging system being used during a planned maintenance (pm).It was reported that the right side tracker of the imaging system was inaccurate.It was reported that the tracker was three millimeters inaccurate.There was no patient present when this issue was identified.

• Brand Name: O-ARM 1000 IMAGING SYSTEM 3RD EDITION
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12033830
• MDR Text Key: 262410928
• Report Number: 3004785967-2021-00801
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/21/2021

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: No Information
• Device Model Number: BI70000028230
• Device Catalogue Number: BI70000028230
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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