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Model Number 560BCS1 |
Device Problems
Device Alarm System (1012); Electrical /Electronic Property Problem (1198); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/29/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation summary: during preventive maintenance by a service technician this bio-console instrument had multiple errors, 4,5 ,6,7,8,9 and 100, associated with the system controller, there was excess of heating on card and it did not allow measurements or adjustments to be made (variation in values), damage was diagnosed in system controller.The issue will be resolved by replacing the system controller to evaluate the other cards.Preventive maintenance was completed per specifications.Note: the instrument was analyzed/serviced in the facility by a field service technician.The instrument did not return to a medtronic facility for service.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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During preventive maintenance by a service technician this bio-console instrument had multiple errors, 4,5 ,6,7,8,9 and 100, associated with the system controller, there was an excess of heating on the card and it did not allow measurements or adjustments to be made (variation in values), damage was diagnosed in the system controller.This was detected during service so there was no patient involvement, so no adverse effect occurred.
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Search Alerts/Recalls
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