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Model Number N/A |
Device Problem
Low Battery (2584)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/16/2018 |
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 getinge field service engineer (fse) evaluated the iabp and replaced the battery to resolve this issue.The fse then ran battery runtime test, performed functional, and safety checks to meet factory specifications.The iabp was then released back to the customer, and cleared for clinical use.The initial reporter's full name was abbreviated as the name exceeded maximum character limit.The complete name is, (b)(6).The initial reporter's phone number is (b)(6).
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Event Description
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It was reported that, while transporting a patient from the hvac unit (heating, ventilating, and air conditioning) to the icu (intensive care unit), the cs300 intra-aortic balloon pump (iabp) ran for a minimum of 30 minutes then the battery was low.The iabp continued to work and was reconnected to the mains in the icu.There was no patient injury or adverse event reported.
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Search Alerts/Recalls
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