MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
|
Back to Search Results |
|
Model Number BI70000028120 |
Device Problem
Radiation Output Failure (4027)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/22/2024 |
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: bi71000122.H3) no parts have been received by the manufacturer for evaluation. codes: b17, c20, d15 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 in an unknown procedure.It was reported that the system "would not spin" when attempting to scan a patient.The site contact reported that they instructed the site to restart the system, which did not resolve the issue.No further information available at this time.Patient impact and surgical delay unknown.Medtronic imaging was aborted, but the surgery was not.
|
|
Event Description
|
Additional information was received.It was reported that the issue occurred during a sacroiliac and thoracolumbar procedure.They used a different medtronic imaging system to complete the case.There was a delay of 15 minutes and no impact on the patient's outcome.
|
|
Manufacturer Narrative
|
H3/h6: the system was serviced and the ethernet strain relief connector was replaced.Codes b01, c07, and d02 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.
|
|
Search Alerts/Recalls
|
|
|