Model Number N/A |
Device Problems
Battery Problem (2885); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/23/2017 |
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) 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 verified that the battery would not charge.The fse replaced the batteries and performed all functional and safety tests to factory specifications.The iabp was returned to the customer for clinical use.
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Event Description
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Customer reported that a strange fan noise and battery issues occurred on the on a cardiosave intra-aortic balloon pump (iabp).The circumstances of the event are unknown; however, no patient involvement or adverse event was reported.
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Event Description
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Customer reported that a strange fan noise and battery issues occurred on the on a cardiosave intra-aortic balloon pump (iabp).The circumstances of the event are unknown; however, no patient involvement or adverse event was reported.
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Search Alerts/Recalls
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