MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
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Model Number BI70000028120 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.Testing revealed that the system booted up as normal and the issue could not duplicate the issue.A quick glance at the logs revealed nothing that stood out as abnormal.Both x-ray and motion battery voltage/charger voltage were normal and within spec.They replaced the cmos battery for the ias cpu as a precautionary measure.Visually the umbilical looked worn but seemed to function as normal (connection was immediate once plugged in).Several 2d images/3d spins were completed with success.Rebooted the system several times with success.System is fully functional, staff notified.Trained on a few tips and pointers for troubleshooting (reseating umbilical, ctrl q, manually opening door with ratchet, yellow door override button.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information regarding an imaging system that was being used for a sacroiliac and thoracolumbar procedure.It was reported that they received another "system booting, please wait" error and were unable to resolve this issue through rebooting the system.They decided to abandon the procedure.Surgery was aborted, imaging aborted and navigation was aborted.There was no reported delay and no patient impact to outcome.
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Event Description
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Additional information received from a manufacturer representative reported that the case was not aborted.
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Manufacturer Narrative
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See b5.A1-a4: patient information provided.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.
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