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

Model Number BI70002000

Device Problems Communication or Transmission Problem (2896); Data Problem (3196)

Patient Problem No Patient Involvement (2645)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.The manufacturer representative went to the site to test the imaging system.The reported issue was confirmed and the lost ip default gateway was re-entered.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 after the site changed the ip address inside the tech services console, the newly input ip address would not save.As a result, they were unable to properly send images anywhere.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: 8611766
• MDR Text Key: 145105949
• Report Number: 3004785967-2019-00883
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00643169639683
• UDI-Public: 00643169639683
• 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,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/15/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2017
• 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