MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
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Model Number BI70000028120 |
Device Problems
No Display/Image (1183); Noise, Audible (3273); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr: a representative went to the site to preform a system check out it was noted that the reported issue was that there was beeping and the system would not shoot x-rays.The replaced the motor charger board and battery monitor board, system checkout passed, staff notified that system is fully functional inspection of logs show error 25 (low battery) and battery monitor board led malfunction, tested all 3 chargers boards and there were several individual chargers that were charging above specs.Replaced all 38 batteries along with charger 1 & 2.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 being used during a spinal procedure.It was reported that when the site was taking the lateral and ap images, there was a beeping noise and the images were not taken.There was no reported delay to the procedure.There was no reported impact to the patient.2021-mar-25 e1 (rep) additional information was received.It was reported that to troubleshoot at the time of the event, the system was turned off and rebooted.The foot switch was plugged in to bypass hand control.The gantry was opened and closed.None of these resolved the issue.
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Manufacturer Narrative
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Concomitant products part number: bi30000148, lot: rev.1 : s/n (b)(6) the battery monitor board was installed in the test system.It was confirmed that the battery indicator shows it is functional and charging.System booted, readied and ran without any issues.However, it failed to take 2d and 3d images.Confirming that there was a electrical component failure.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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Search Alerts/Recalls
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