MAUDE Adverse Event Report: SANMINA -SCI SYSTEMS O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number BI70002000

Device Problems Device Damaged Prior to Use (2284); Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: section d: information references the main component of the system.Other relevant device(s) are: product id: bi71000907, serial/lot #: (b)(6).The system was serviced in the field, and the medtronic representative (rep) replaced the mobile view station (mvs) computer and loaded the 4.2.1 software.Codes b01, c07, d02 are applicable to this analysis.The system was serviced in the field once again and the same error re-occurred when the radiologic technologist (rt) was doing user training.The rep talked about the issue with a different rep (rep 2) and ordered another mvs pc, and an mvs power board.The returned to the site and reviewed logs from the previous day, and the date that the case was initially opened.Each time that the error message was displayed to the user, there were the same errors proceeding the message in the logs."failed to create bi database.", "the type initializer for 'bi.Oarm.Mvs.Database' threw an exception.", "open failed.Can not open due to remote calibration files not updated.", "exception: open failed.Can not open due to remote calibration files not updated.", and "critical error: database is not initialized".Based on this, the rep 1 inspected, and reseated both ssd's, and reinitialized the database.When the case was first called in the error was coming up on every boot up, and rebooting was not clearing the error.The error was now coming up intermittently.They had rebooted the system over 30 times, the error only occurred twice, and rebooting did clear the error both times.They contacted another rep (rep 3), and waited at the site, while he reviewed the logs, and contacted the factory.When he called back, he had rep 1 reload both windows10, and the software.Rep 1 rebooted the system about to more times, without getting any errors.Codes b01, c13, d02 are applicable to this analysis.D9, h2, h3: the hardware was returned and analysis was performed.The reported complaint able to be confirmed.The mvs computer failed a bench test.Os and image acquisition system (ias) application failed to load.The mvs computer failed to boot pass system integrity error.Codes b01, c02, d02 are applicable to this analysis.H6: multiple fdd/annex a codes were reported.A0204 was coded for the error message.A1102 was coded for new install issue.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that while booting the system, an error message occurred stating "an error has occurred that may have changed the system's integrity.Please restart the image acquisition system (ias) and mobile view station (mvs)." the site performed a hard reboot and the error message was still present on system.It was noted this was a new install. there was no patient involvement.Additional information later received from a manufacturer representative indicated that after computer replacement, the same error reoccurred when the site was doing training.Initially, the error would appear upon bootup, but now the errors were occurring intermittently.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SANMINA -SCI SYSTEMS; km 15.5 no. 29, plant 06; carr. chapala-guadalajara,jal 45640 ; MX 45640
• Manufacturer (Section G): SANMINA -SCI SYSTEMS; km 15.5 no. 29, plant 06; carr. chapala-guadalajara,jal 45640 ; MX 45640
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18944905
• MDR Text Key: 339015650
• Report Number: 3006544299-2024-00221
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00763000616564
• UDI-Public: 00763000616564
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200074
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2023
• 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
• Treatment: "SEE H11"