MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SYSTEM, 9732719, O-ARM 1000; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number 9732719

Device Problems Component Missing (2306); Wireless Communication Problem (3283)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Onsite functional and visual examination was performed by a manufacturer representative.The issue could not be replicated.The system passed a system checkout and was returned to an operational condition.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging device being used for an unknown procedure.It was reported one of the trackers on the system was missing.The site was able to use the system for a case by using the trackers on the other side of the system.There was no other information about how the tracker was lost or if there was any other damage.There was no reported impact to patient outcome, and no reported delay.It was confirmed that the trackers were not lost, but unable to verify.

• Brand Name: SYSTEM, 9732719, O-ARM 1000
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8367604
• MDR Text Key: 137077845
• Report Number: 1723170-2019-00780
• 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,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/25/2019

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: 9732719
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1