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Model Number N/A |
Device Problem
No Audible Alarm (1019)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/21/2020 |
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) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.Getinge service has not been requested by the customer, so we are unable to complete an evaluation.If provided, we will send a supplemental report with our additional findings.Not returned to manufacturer.
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Event Description
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It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) did not alarm.Three hours after the intra-aortic balloon (iab) was inserted, when the iabp display was confirmed, the diastolic augmentation pressure hardly increased, and the iab pressure waveform increased only about half of the normal pressure.No alarm sounds.The alarm was not muted.When the iab was refilled, it started working without problems.No patient harm, serious injury or adverse event was reported.
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Manufacturer Narrative
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A getinge service representative reported that there were no anomalies or malfunction reported from the customer.Thus any repair for this iabp unit was not required.
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Event Description
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It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) did not alarm.Three hours after the intra-aortic balloon (iab) was inserted, when the iabp display was confirmed, the diastolic augmentation pressure hardly increased, and the iab pressure waveform increased only about half of the normal pressure.No alarm sounds.The alarm was not muted.When the iab was refilled, it started working without problems.No patient harm, serious injury or adverse event was reported.
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Search Alerts/Recalls
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