Model Number BI70002000 |
Device Problems
Smoking (1585); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3) the manufacturer representative went to the site to test the imaging system.The isolated standalone board was replaced.Rad and fluoro calibration was performed.System functions checked.After replacement of the broken the issue was solved.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: b i71000225, lot/serial #: unknown.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 something burned/popped during bootup and the system refuses to boot up.While being onsite to replace the upper door cap, the manufacturer representative turned on the system and heard a popping noise and a burning smell came from the fans close to the handle.Troubleshooting was performed and they measured all voltages from the umbilical to isolated stand alone board and there are was no voltages going out from the isolated stand alone board.They also saw a couple of resistors burned and popped.The probable cause was that there was a broken isolated stand alone.The next step was to replace the stand alone board.No patient was present at the time of the event. .
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Manufacturer Narrative
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H3) the manufacturer representative went to the site to test the imaging system.Troubleshooting was performed, and they saw that the generator stand alone board was off.The isolated stand alone board was off.The measured the voltages on the power tray, power enclosure, line filter, and they checked the fuses.In the end the voltage stopped at isolated stand alone board.The isolated stand alone board was replaced.Rad and fluoro calibration was performed.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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Manufacturer Narrative
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H3: the printed circuit board assembly (pcba) generator isol was returned to the manufacturer for analysis.Analysis found that it was not possible to bench test due to overstressed components.Visual inspection showed components r19, r20, and r21 were electrically overstressed.Analysis found that the reported event was related to an electrical issue.H6: fdm b01, fdr c02, and fdc d02 are applicable to the hardware 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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Search Alerts/Recalls
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