Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that the system was being wheeled out into the hallway and a loud popping sound, "like a balloon pop," was heard, smoke was smelled and seen coming from the image acquisition system (ias).The system would not turn on anymore. there was no patient involvement.
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H6) no parts have been received by the manufacturer for evaluation.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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H2) continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000860, serial/lot #: unknown, product id: bi71000714, serial/lot #: unknown, product id: bi71000861r, serial/lot #: unknown, product id:bi71000457 , serial/lot #: unknown, product id: bi71000457, serial/lot #: unknown, product id: bi71000464, serial/lot #: unknown, product id: bi71000464, serial/lot #: unknown h2) a manufacturer representative (rep) went to the site to test the imaging system.The rep found that the system was not allowing 400 volts alternating current (vac) to pass through the power tray due blown power tray.The fuses were replaced for troubleshooting purposes and did not solve the issue.The rep also found that the power converter was not supplying 96 volts (v).The rep replaced the power tray and the converter.The system then performed as intended.Codes: b01, c02, d02 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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