Model Number BI70000027230 |
Device Problems
Battery Problem (2885); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/16/2019 |
Event Type
malfunction
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Manufacturer Narrative
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No patient information provided as no patient was involved in this concern.No parts have been returned to the manufacturer for 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 an imaging device being used outside of procedure.It was reported that when booting up the imaging system, it remained black.There were no booting lines on the screen and they could hear a « tic tic tic » noise repeatedly at the back of the mobile view station (mvs), coming from the uninterruptible power supply (ups).Fuses were found to be good.The noise occurred when pressing the on/off button or the test button.No patient present.
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Manufacturer Narrative
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"date received by manufacturer" date on follow-up2 mdr was 2019-04-24.The hardware investigation of the returned uninterruptible power supply (ups) found that the reported event was related to an electrical issue with the battery.The reported event was confirmed.When the ups was powered on, "batt low" and "fault" errors leds were lit up.Ups was functional with new battery.The failure mechanism was that the battery would not hold a charge.The component was replaced and the issue was resolved.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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A manufacturer representative went to the site to test the imaging system.The system performed as intended at the time of the system checkout.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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The hardware evaluation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.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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Analysis of the power supply.
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Search Alerts/Recalls
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