Model Number 0998-00-3023-53 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The full name of the event site was shortened due to field character limit; the full name is (b)(6) hospital.A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse checked the unit and found electrical test fail code 35 was on the unit's display.The fse reset all the connections and also reset the datasets.The display was still showing.The supply voltages were checked but the error was still showing.The fse needs datasets for further testing.The repairs are still ongoing.
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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) had an electrical test fail code 35.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.
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Event Description
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It was reported that prior to use, the cs300 intra-aortic balloon pump (iabp) had an electrical test fail code 35.There was no patient involvement.
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Event Description
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N/a.
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Manufacturer Narrative
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Additional fields: e1(event site state: (b)(6).It was reported that the cs300 intra aortic balloon pump (iabp) had an electrical test fail code 35.Getinge field service engineer (fse) checked machine and found that there was error electrical test fail code 35 showing on display.Reset all connections and also reset the datasets but still the error showing.Checked supply voltages all found ok.Suspected the data set issue.Need datasets for further testing purpose.Issue with main board so replaced main board (d670-00-0788) issue get resolved.No patient involved.
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Search Alerts/Recalls
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