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 Problem
Radiation Output Failure (4027)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3, h6: a medtronic representative went to the site to test the equipment.Testing revealed that no 96 vdc to controllers.Motion co ntrollers were all stuck on "configured".There was a active move enable signal to each controller, shown in dmc smart terminal.Further troubleshooting indicated a faulty pendant with possible stuck button allowing move enable during startup.The manufacturer representative replaced the pendant and resolved all faults.The imaging system then passed the system checkout and was found to be fully functional.B01, c13, d02 are applicable.H3, h6: the computer was returned but analysis was not yet completed.B21, c21, d16 are applicable.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000645, serial/lot #: (b)(6); rev.3; product id: bi71000489, product id: bi71000093; product id: bi71000537r.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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Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that the system is able to get past standalone mode but will not let them take a 3d spin. there was no patient involvement.
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Manufacturer Narrative
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H2: products bi71000645 (lot number 1792844 rev.3), bi71000489 (lot number 101432485 rev.7), and bi71000093 (lot number 111437055 rev.3) were returned and are pending analysis.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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Manufacturer Narrative
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H2) continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000645, serial/lot #: (b)(6) rev.3, product id: bi71000489, serial/lot #: (b)(6) rev.7, product id: bi71000093, serial/lot #: (b)(6) rev.3 the mobile view station (mvs) computer was returned to the manufacturer for evaluation.After functional testing, performance testing, visual/physical examination, and usability inspection, the reported issue was not confirmed.The results of the analysis concluded that no failure was found.Codes: b01, c19, d14 the system control plate was returned to the manufacturer for evaluation.After functional testing, performance testing, visual/phys ical examination, and usability inspection, the reported issue was not confirmed.The results of the analysis concluded that no failure was found.Codes: b01, c19, d14 the mobile view station (mvs) power board was returned to the manufacturer for evaluation.After functional testing, performance tes ting, visual/physical examination, and usability inspection, the reported issue was not confirmed.The results of the analysis concluded that no failure was found.Codes: b01, c19, d14 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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