MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
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Model Number BI70002000 |
Device Problems
Calibration Problem (2890); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009); 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 09/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: other relevant device(s) are: product id: bi71000860, product id: bi71000221, serial/lot :(b)(4).A medtronic representative went to the site to perform a system check out and they found the representative moved the system to another or and had to go down a ramp to do so.Midway down the ramp it stopped and lost drive, and the representative had to manually drive it to the or.The representative found that 96vdc was missing.This was the reason the drive stopped working.The representative replaced the power conversion to resolve the missing 96vdc, and the digital drive board was replaced as a precaution.The system now functioned as intended.B01, c02, d02 are applicable to the system checkout.The digital drive board was returned for product analysis.The analysis is still in progress.B21, c21, d16 are applicable the product 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 a navigation device being used during a procedure.It was reported that the site brought the system in and placed it around the patient, but the door would not close.They were unable to move the gantry.The system would not open, so the site could not remove the system from around the patient.The site eventually removed the system from around the patient and saw a calibration message.The site attempted to complete the calibration and the system got stuck at it's highest point and they were unable to get it out the door.The site brought in a new system to complete the procedure.The gantry was able to move out of the way.There was no patient harm and the procedure was delayed less than one hour.
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Manufacturer Narrative
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H2) additional information: continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000860, lot number: rev.2 - s/n: (b)(6) h3: the power conversion was returned to the manufacturer for analysis.Analysis found that the reported issue could be confirmed.The power conversion was faulty.Analysis found that the reported event was related to an electrical issue.(b01, c02, d02) h3: the digital drive board was returned to the manufacturer for analysis.Analysis found that the reported issue could not be confirmed; no failure was found with the returned digital board.(b01, c20, d15).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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