Model Number N/A |
Device Problem
Inaccurate Synchronization (1609)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided.A supplemental report will be submitted when additional information is made available.
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Event Description
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It was reported that the blood pressure readings/fiber optic pressure values on the cardiosave intra-aortic balloon pump (iabp) were questionable between the fiber optic catheter and the blood pressure monitoring system.It appears that this occurred during use on a patient, but this has not yet been confirmed.However, there was no adverse event reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) has reported that he is finding it hard to obtain any further information regarding this complaint.The end user was questioning the difference between the blood pressure reading measured at the tip of the fiber optic balloon in comparison with a reading taken from the radial transducer in the arm, however, getinge sales/clinical support has explained the reasons for this to the customer and from all indications, this has satisfied them.All addition attempts to obtain further information have been unsuccessful, but if pertinent information is received in the future, a supplemental report will be submitted.
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Event Description
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It was reported that the blood pressure readings/fiber optic pressure values on the cardiosave intra-aortic balloon pump (iabp) were questionable between the fiber optic catheter and the blood pressure monitoring system.It appears that this occurred during use on a patient, but this has not yet been confirmed.However, there was no adverse event reported.
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Search Alerts/Recalls
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