MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
|
Back to Search Results |
|
Model Number BI70000028230 |
Device Problems
Calibration Problem (2890); Positioning Problem (3009); Application Program Freezes, Becomes Nonfunctional (4031)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/27/2022 |
Event Type
malfunction
|
Event Description
|
Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that there were several issues discovered by the biomedical engineer at the site.It was reported that the system did not go into lateral or ap position, collision zone.It was not replicated by the biomed so it seemed to be a user issue.There was a delay in initialization of 3d acquisition.Navigation was ready, the spheres were seen, and the rj45 cable was ok.When the site started the 3d sequence, the system went in zero position and stopped.It was not possible to get further.They rotated the tube and detector approximately five degrees and restarted the sequence to get the 3d by pushing the 3d button on the switch.It was then possible to take a 3d image.It was also noted that calibration failed.It was not possible to perform x-ray detector gain calibration.There was no patient involvement.
|
|
Manufacturer Narrative
|
No products have been returned to medtronic for analysis.(b)(4).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.
|
|
Event Description
|
The resolution of the reported issue was start the rad calibration then adjust the settings for fluoro calibration starting at 40kv.The reported issue was resolved.
|
|
Manufacturer Narrative
|
H2) additional information was added to 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.
|
|
Manufacturer Narrative
|
Continuation of d11: section d information references the main component of the system.Other relevant device(s) are: product id: bi-500-00186, version #: 3.2.1.H3) the software logs were reviewed.It was determined that this was not a software issue.Complaint data investigation found the event was due to a user workflow error as per the reported issue stated "the resolution of the reported issue was start the rad calibration then adjust the settings for fluoro calibration starting at 40kv.The reported issue was resolved." software functioning as designed.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.
|
|
Search Alerts/Recalls
|
|
|