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

Model Number BI70002000

Device Problem Poor Quality Image (1408)

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

Event Date 03/21/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: m021083c001, software version #: 4.2.1.H3, h6: the system was serviced in the field by a medtronic representative.The rep ran rad/gain calibration and extended rad/gain calibration separately while rebooting in between attempts.Verified 20 and 40cm fov spins appeared normal.The rep enabled 2dlf feature and completed long film gain calibrations.The rep trained the radiologic technologist to perform rad/gain calibrations individually.Codes b01, c13, and d02 are applicable.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 during a sacroiliac and thoracolumbar procedure.It was reported that after acquiring a 3d spin, all planes appeared entirely black.The 3d spin automatically transferred to the navigation system, and all planes but sagittal appeared entirely black, as well.The sagittal plane appeared entirely white.The same issue occurred with the next 2 scans.The 2d scout shots appeared as expected.Troubleshooting was performed.Multiple reboots were attempted, with no effect.The local representative (rep) was unable to change brightness and contrast on the navigation system.The level and width buttons appeared and could be pressed but the appearance of the images was unchanged.There were no error messages that appeared during any of the scans.All scans were 40 cm fov.On the mobile viewing station (mvs), the rep attempted again to change the brightness and contrast.Holding brightness for a long period of time resulted in all 3 planes appearing entirely white.The rep confirmed that no constructs were present in the patient's anatomy.It was confirmed that there was nothing in the gantry aside from the pat ient and reference frame. the procedure was aborted.There was no reported delay prior to aborting the procedure.There was no reported impact to the patient.

Event Description

Additional information was received.It was reported that the procedure was aborted after anesthesia had been administered and an incision had been made.Another procedure will need to be scheduled to complete treatment.

Manufacturer Narrative

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.

Manufacturer Narrative

H3, h6: software analysis was completed.There was enough evidence to say that a software anomaly occurred.Codes b01, c10, and d18 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: 18980708
• MDR Text Key: 339337371
• Report Number: 3006544299-2024-00241
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 03/21/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2023
• 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...
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 100 KG