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

Model Number 9732719

Device Problems Problem with Software Installation (3013); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: bi71000110r, serial/lot #: (b)(4).A medtronic representative went to the site to test and service the equipment.The mobile view station (mvs) computer displayed that 'bootmgr' was missing.The mvs computer was replaced.The system then passed the system checkout and was found to be fully functional.The mvs computer was returned to medtronic but was under analysis at the time of filing.Device manufacturing date unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging device.It was reported that a medtronic representative (rep) was working on the system and was unable to update the software.Additionally, the mobile view station (mvs) computer was no longer booting up.It was noted that ¿bootmgr¿ was missing.There was no patient involved.

Manufacturer Narrative

Device evaluation: analysis was completed for the mobile view station (mvs) computer.Functional testing, performance testing, and visual/physical examination were performed, and the reported problem was confirmed.The missing boot disk was confirmed.After a software install, however, the system was back to normal.It was determined that there was a software failure with the mvs computer with a failure mechanism of a corrupt operating system.If information is provided in the future, a supplemental report will be issued.

• 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 st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8857370
• MDR Text Key: 153225925
• Report Number: 3004785967-2019-01364
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 08/02/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 09/30/2019
• 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