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Model Number 560BCS1 |
Device Problems
Electrical /Electronic Property Problem (1198); Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation summary: during preventive maintenance by service technician, it was observed that the bioconsole 560 instrument had a power supply issue.The issue was resolved by replacing the power supply and applying the front housing overlay.Preventive maintenance was completed per specifications.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 bioconsole 560 instrument had the charge indicating light on the front keypad was not working.This was detected during service so there was no patient involvement, so no adverse effect occurred.
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Manufacturer Narrative
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Update to h6: device codes (fdd/annex a) included.H11 device evaluation summary correction: during preventive maintenance by a field service technician, it was observed that the charge indicating light was not working.The field service technician replaced the batteries in an attempt to fix the charging light.The charge indicating light was still not working upon replacing the batteries.The field service technician replaced the 560 base unit keypad membrane to attempt to fix the led but the problem remained.While attempting to complete the preventive maintenance, the field service technician found the flow board calibration to be out of tolerance.This issue was resolved by replacing the flow board.The filed service technician noticed that the 560 power supply needed a complete repair.The customer requested that the instrument be sent into the service depot for repair.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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