Model Number BI70000028230 |
Device Problems
Data Problem (3196); 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 01/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The system was serviced in the field.During the booting up process the system sent a message related to the database and it was not possible to fix.The database file was restored from the backup but the problem persisted.It was noted that a new installation of the software would need to be performed.A second system service was done and the software was re-installed.The failure was resolved.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 an unknown procedure.It was reported that when the system was turned on, the equipment displayed the error, "failed to get data" and the attempt to fetch logical page (1:260) in database 5 failed.It belongs to the allocation unit.The mobile viewing station (mvs) did not turn on completely but the image acquisition station (ias) was booting without problems.Imaging was aborted.There was no impact to the patient.It was unknown if there was a delay.
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Event Description
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Additional information was received stating the correct event date and aware date is 2021-jan-22.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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