MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
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Model Number BI70002000 |
Device Problems
Mechanical Problem (1384); 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 10/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Section d references the main component of the system.Other medical products in use during the event include: product id: bi71000194, lot/serial #: unknown ; product id: bi71000529, lot/serial #: unknown h3) the manufacturer representative went to the site to test the imaging system.Hardware parts were replaced. 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 had a bootup problem, the motion bar did not verify.The system didn't finish the bootup.One of the buttons stayed pressed. there was no patient involvement.
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Manufacturer Narrative
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Lot numbers added to products in section d10.Continuation of d10: product id: bi71000529, lot number: 26117d 0005 rev.1; product id: bi71000194, lot number: 434433 rev.E h3, h6: product bi71000529 was received by the manufacturer for analysis.Installed pendant on an imaging test system.The system and pendant booted and readied.Perform 2d and 3d imaging successfully.All pendant functions actuated correctly.No functional problem found.Visual inspection shows the pendant laminate was lifting/ bubbling up from around the keys and the face of the pendant.Physically damaged pendant.B01, c07, and d02 are applicable.H3, h6: product bi71000194 was received by the manufacturer for analysis.Installed hand switch in the imaging test system.The system initialized.Motion, generator, communication and charging readied.2d and 3d images were successful.No failure was found.B01, c19, and d14 are applicable.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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