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); Positioning Problem (3009)

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

Event Date 01/31/2024

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: bi71000442r, serial/lot #: (b)(6) h3: a medtronic representative went to the site to test the equipment.Testing revealed that during system installation, the imaging system was not docking and the rotor was not spinning.The manufacturer representative checked and reseated all connections from the gantry rotor to the power conversion board.When trying to re-home the rotor would not spin, and the controller turned red led on and the rotor motor made a clicking noise as if the motor supply power and brake signal were activating at the same time.The manufacturer representative manually ratcheted the rotor with no obstruction.The manufacturer representative set the run level to 8 and the system was able to do a full spin.The manufacturer representative connected to lab view, and all voltage were within specifications.The manufacturer representative manually put the rotor into position to open the door (inserting the pin), with no re-homing.The gantry door did not open due to the rotor never reaching the 184 degrees.The manufacturer representative replaced the gantry m otion controller with no success, and also checked the rotor home sensor that was okay.The manufacturer representative performed troubleshooting with the clutch disengaged and the handle-switch activated (driving the system) forward and suddenly backwards.The sy stem drive wheels stopped and started beeping with voltage lost.Installation was not completed.H6: b01 and d02 are applicable for the system checkout.Multiple fdr/annex c codes were reported.C13 was coded for the imaging system was not docking.C07 was coded for the imaging system rotor not spinning even with no obstruction.C02 was coded for the replaced gantry motion controller.Multiple fdd/annex a codes were reported.A0204 was coded for the system experiencing issues when installed.A1502 was coded for the difficulties when docking.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that while installing the new system, the manufacturer representative (rep) was experiencing difficulties with docking. there was no patient involvement.

Manufacturer Narrative

H3/h6: product bi71000442r (lot number: g081023041 rev.E) was returned and analyzed.Analysis determined that there was no failure found with the gantry motion controller.Codes b01, c19, and d14 apply.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.

• 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: 18793865
• MDR Text Key: 337517829
• Report Number: 3006544299-2024-00160
• Device Sequence Number: 1
• Product Code: OWB
• 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,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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: 02/14/2024
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2023
• 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...."