Catalog Number 0998-00-3023-53 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.Additional information has been requested, however, no further details have been provided.If any additional information is provided in the future a supplemental report will be provided.
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Event Description
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The customer reported that prior to the cs300 intra-aortic balloon pump (iabp) being used on a patient, it displayed an optical sensor failure message.No adverse event has been reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched and reported that the fiber optic assembly was replaced to fix the issue.The fse completed the preventive maintenance (pm) with full calibration of the iabp.The iabp passed all functional and safety tests per factory specifications and was returned to the customer, cleared for clinical use.
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Event Description
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The customer reported that prior to the cs300 intra-aortic balloon pump (iabp) being used on a patient, it displayed an optical sensor failure message.No adverse event has been reported.
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Search Alerts/Recalls
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