Model Number N/A |
Device Problems
Device Inoperable (1663); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/31/2017 |
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 replaced complete display.The iabp's touchscreen then worked normally, and the iabp passed all functional and safety tests to factory specifications and was returned to clinical service.
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Event Description
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Customer reported that while in use on a patient, the cardiosave intra-aortic balloon pump (iabp) touchscreen did not respond to some inputs (the timing menu not possible to open).However, the iabp continued to provide therapy but was subsequently replaced.No death or injury was reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the intra-aortic balloon pump (iabp) and was unable to duplicate the customer's complaint.The fse confirmed that there was no failure of the iabp touchscreen and that it worked normally.However, the fse cleaned the plug body of the coiled cord and connector with flux remover, aerosol and aerosol duster, 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 while in use on a patient, the (b)(4) intra-aortic balloon pump (iabp) touchscreen did not respond to some inputs (the timing menu not possible to open).However, the iabp continued to provide therapy but was subsequently replaced.No death or injury was reported.
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Search Alerts/Recalls
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