Other relevant device(s) are: product id: bi71000053, serial/lot : unknown.The x-ray technician's contact information has been requested.A medtronic representative went to the site to perform a system check out and they found that the power cord was damaged.The power cord was replaced and the system functioned as intended.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that the x-ray technician brought the system inside of a room, plugged the system into an outlet, and the power cord started sparking.The line power indicator on the mobile viewing station was also blinking.The power cord was swapped to another outlet and sparking still occurred.There was no patient involvement.
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H2) additional information: see b5 and e1.H2) correction: see g3.Correct report sources are health professional and company representative.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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