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Model Number 560BCS1 |
Device Problems
Device Alarm System (1012); Electrical /Electronic Property Problem (1198); Smoking (1585); Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation:the reported issues of the instrument alarming when it was powered on, the faulty blood control and detection system and the fact that the instrument would not work, were verified during service.The issues were resolved by replacing the blood detection control system.Preventative maintenance and post repair testing were performed per specifications.Instrument was not returned to medtronic but was serviced by field service technician event date month and year valid 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 that prior to use, this bio-console 560 instrument alarmed when it powered on and it would not work.The customer stated that the blood control and detection system were also faulty.The use of the instrument was unspecified.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that after turning on the power, the customer observed smoke coming from the instrument.The customer stated that there was no power issue.
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Manufacturer Narrative
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Additional information b5: medtronic received additional information that the customer used a back-up instrument for the procedure after observing the issue but it was another brand of instrument that was used.Correction g2.4 (e): the 510(k) number has been updated correction h2.4: the device manufacture date has been updated correction d4: the model, serial number and udi has been updated correction d1: the brand name has been updated 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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