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

Catalog Number BI70002000-G27

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Unique device identification (udi) is unavailable.Device manufacturing date is unavailable.A manufacturer representative went to the site to test the equipment.It was identified the mobile view station (mvs) cart had a blue light but was not responding to shutting off.The image acquisition system (ias) started up normally.The mvs computer was opened and the off button was pressed.The mvs monitor displayed the application on the screen.Logs were pulled successfully.When an x-ray was attempted, an unrelated warning was given indicating the calibration file could not be found.It was directed to restart the system.The mvs cart was restarted by pressing the power button for about a second.The mvs worked normally without any errors.The issue could not be replicated after multiple restarts.Further troubleshooting with the site indicated the person moving the system had pressed lots of buttons and turned the key switch off without shutting off the system.The event logs showed unrelated low voltage errors as the system had not been charged after using it the day prior.The system was left charging and it was confirmed the low voltage errors were gone.The batteries were charging correctly.The imaging system passed the system checkout and was found to be fully functional.The issue could not be replicated.No parts have been received by the manufacturer for evaluation.Part not returned.

Event Description

Medtronic received information regarding an imaging device.It was reported that the umbilical cord was damaged and imaging system was not taking/holding charge.No patient was present.

Manufacturer Narrative

Additional information: unique device identification (udi) and device manufacture date provided.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer Contact: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7516992
• MDR Text Key: 108362962
• Report Number: 1723170-2018-02069
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: TN
• 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,Followup
• Report Date: 06/11/2018

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: Radiologic Technologist
• Device Catalogue Number: BI70002000-G27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 05/31/2018
• Supplement Dates FDA Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2016
• 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