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Model Number N/A |
Device Problem
Failure to Run on Battery (1466)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/19/2018 |
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.At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested from the customer with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.The full name of the event site noted, is (b)(6).
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Event Description
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It was reported during field action, the (b)(4) representative discovered the cs300 intra-aortic balloon pump (iabp) batteries voltage and current were out of specification.The iabp unit cannot switch from ac to battery.There was no patient involvement, and there was no adverse event reported.
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Search Alerts/Recalls
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