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Model Number 560A |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2020 |
Event Type
malfunction
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Event Description
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Medtronic received information that during use of the bio-console base, external motor drive and flow transducer instruments a motor controller malfunction error occurred and was normalized after repeated reboots.In addition, a back-flow alarm occurred several times although the flow zero setting was normally completed.The back-flow level was slowly normalized automatically without any other manipulation, but it occurred irregularly during surgery, causing difficulty.The customer stated that they could not understand why the error occurred frequently, even though there was no cause for back-flow.The customer also, stated it slowly came back to normal in approximately 3 minutes.The instruments were replaced with back-ups and there were no reported adverse patient effects.Additional information received confirms there was no impact to the patient and the hand crank was required.The customer said that ¿motor controller malfunction¿ message suddenly appeared.There were no external factors.After 1 to 3 times rebooting, the issue was solved.Additionally there was a sudden backflow alarm.Per the attached file, backflow range was about -2.09.The customer did zero the setting on the flow transducer, and checked the external factors but they could not find anything.The backflow range slowly returned to normal by itself.
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Manufacturer Narrative
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Device evaluation summary: the reported motor controller malfunction error and back-flow issues were not verified during service.The service technician was unable to duplicate the issues.The external motor drive was tested with a bio-console and no problems were noted.The magnet cover was replaced as part of the preventative maintenance.Preventive maintenance was performed per specifications.Conclusion: the reported motor controller malfunction error and back-flow issues was not verified during service.There were no pati ent/clinical safety issues reported.The service history record was not reviewed as returned product analysis found no evidence of servicing issues with the serviced device.Trends for issues with this product are reviewed at quarterly quality meetings.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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