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
Failure to Run on Battery (1466); 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 07/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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No products have been returned to medtronic for analysis.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 used during a procedure.It was reported that the site was able to take 2d images, however, when trying to take a 3d spin, the system was not exposing.They took it outside of the room to troubleshoot.Their radiologic technologist (rt) performed rad and fluoro gain calibrations hoping that it would resolve the issues, however it did not.There was a reported delay to the procedure of less than one hour.There was no reported impact to the patient.The rt noted that they had found the system unplugged.It had only been plugged in for approximately 2 hours.Technical services (ts) had them unplug the umbilical cable to which the battery light indicators at that point only had 2 bars or 20% charge.Additional information was received.It was reported that the system was unable to expose due to low battery levels.The local representative (fse) had the site keep the system plugged in for several hours and system then performed as intended.
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Event Description
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Additional information was received.It was reported, that the issue occurred, during a 1 level thoracic fusion.
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Manufacturer Narrative
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H2) additional information: see b5.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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