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 10/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.Testing revealed the ias was displaying a "system booting, please wait" error during boot up.System would not boot up all the way.They reloaded the ias software and firmware.They performed multiple reboots with no issues.Performed system checkout and the unit is operational.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 a procedure.It was reported that the ias was displaying a "system booting, please wait" error.They shut down the system, booted the image acquisition system (ias) and mobile viewing station (mvs) separately, reconnected the systems, and were still receiving the system booting error message.They aborted the imaging.The delay was less than an hour with no impact to the patient.
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Manufacturer Narrative
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B5: additional information 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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Event Description
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Additional information was provided stating that the issue was resolved by reloading the ias software and firmware.The cause of the issue was that there was a computer glitch during the bootup cycle which did not allow the unit to bootup successfully.
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Search Alerts/Recalls
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