MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O2; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number BI70002000

Device Problems Data Problem (3196); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Patient Involvement (2645)

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.The unique identifier was not available at the time of reporting.The manufacturer representative went to the site to test the imaging system.The reported issue could not be confirmed because the symptoms could not be reproduced.The system was initializing and booting up correctly, 877 patients in saved exams, and they were able to retrieve past studies.The manufacture date was not available at the time of reporting.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging system.It was reported outside of a procedure that the system was booted on and showed a corrupted database error.No patient was present at the time of the event.

• Brand Name: O2
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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: 8969707
• MDR Text Key: 156753007
• Report Number: 3004785967-2019-01570
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151000
• 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
• Report Date: 09/06/2019

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: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/06/2019
• 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