Model Number N/A |
Device Problems
Defective Device (2588); Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/11/2018 |
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.
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Event Description
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It was reported that during service test by the customer, the cs300 intra-aortic balloon pump (iabp) generated "electrical test fails code #52", and the drive transducer is suspected to be defective.There was no patient involvement and no adverse event was reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp and was able to duplicate the alleged malfunction.To resolve the issue, the fse replaced the drive transducer and performed all calibration, functional and safety tests to factory specifications.The iabp was returned to customer and cleared for clinical use.
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Event Description
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It was reported that during service test by the customer, the cs300 intra-aortic balloon pump (iabp) generated "electrical test fails code #52", and the drive transducer is suspected to be defective.There was no patient involvement and no adverse event was reported.
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Search Alerts/Recalls
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