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Model Number 560BCS1 |
Device Problem
Mechanical Problem (1384)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis and investigation is ongoing for this event.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 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.See the attached images.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 handcrank was required.
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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.See the attached images.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 handcrank was required.
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Manufacturer Narrative
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Initial device analysis: the reported motor controller malfunction error and back-flow issues were not verified during service.The service technician was unable to duplicate the issues during functional testing.Investigation is ongoing and additional information will be provided on completion.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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Manufacturer Narrative
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The bio-console instrument was returned for analysis and the reported motor controller malfunction error and back-flow issues were not verified during service.The service technician was unable to duplicate the issues during functional testing.The service technician found that the instrument had error 67 in the error log.The system controller module was replaced as a precautionary measure due to the error code in the log.Preventive maintenance was performed per specifications.Trends for issues with this product are monitored.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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The customer said that ¿motor controller malfunction¿ message suddenly appeared.There were no external factors.After one to three times rebooting, the issue was solved.Additionally there was a sudden backflow alarm.The 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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Search Alerts/Recalls
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