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Model Number ACT100 |
Device Problems
Device Alarm System (1012); Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation summary: the reported the reported issues of the instrument failing liquid quality control (qc) and displaying error code 69 were verified during service.The service technician observed error codes 11 and 69 in the statistics log.The issues were resolved by replacing the assy flag sensor.Post-repair testing was performed per specifications.The instrument was serviced/analyzed in the facility by a field service technician.The instrument did not return to a medtronic facility for service/analysis.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 of a act plus instrument, it was reported that the instrument failed liquid quality control (qc) and displayed error code 69.The instrument was used.There were no adverse patient effects.
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Manufacturer Narrative
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Medtronic received additional information that the customer obtained control values.The customer stated they were not using this instrument in a case at the time.The instrument was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that quality control is performed twice a day for the instrument.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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