Model Number N/A |
Device Problem
Connection Problem (2900)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/12/2020 |
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 per company standard operating procedure since the device manufacture date is greater than one year from the event date.A supplemental report will be submitted when additional information is provided.
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Event Description
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It was reported that the end-user couldn't read blood pressure reading on the cardiosave intra-aortic balloon pump (iabp) while they connected pressure transducer into it.The end users troubleshoot themselves, and discovered that the connector was heated (which was warm/hot).The end users switched it off immediately and managed to unplug it.The end user discovered the connector was oval shaped.The pressure cable was replaced and monitoring was functional.There was no harm or injury to patient and no adverse event was reported.
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Manufacturer Narrative
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It was reported that the customer performed the troubleshooting with the iabp reported in b5 and that they purchased a new pressure cable from the manufacturer.The iabp is still on-hold at the biomed department.A supplemental report will be submitted when additional information is provided.
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Event Description
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It was reported that the end-user couldn't read blood pressure reading on the cardiosave intra-aortic balloon pump (iabp) while they connected pressure transducer into it.The end users troubleshoot themselves, and discovered that the connector was heated (which was warm/hot).The end users switched it off immediately and managed to unplug it.The end user discovered the connector was oval shaped.The pressure cable was replaced and monitoring was functional.There was no harm or injury to patient and no adverse event was reported.
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Manufacturer Narrative
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A getinge service territory manager (stm) was dispatched to evaluate the iabp.The stm performed a preventive maintenance (pm), and performed all calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The iabp was then handed over to the customer in good working condition.
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Event Description
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It was reported that the end-user couldn't read blood pressure reading on the cardiosave intra-aortic balloon pump (iabp) while they connected pressure transducer into it.The end users troubleshoot themselves, and discovered that the connector was heated (which was warm/hot).The end users switched it off immediately and managed to unplug it.The end user discovered the connector was oval shaped.The pressure cable was replaced and monitoring was functional.There was no harm or injury to patient and no adverse event was reported.
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Search Alerts/Recalls
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