Model Number N/A |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/25/2017 |
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.
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Event Description
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During in-service training the customer reported that the auto button on the cs100 intra-aortic balloon pump (iabp) did not work.There was no patient involvement or adverse event reported.
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Manufacturer Narrative
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A company representative made various attempts to retrieve additional information in regards to repair information.Unfortunately, there was no further information provided.If any details of this event is provided a supplemental report will be provided.
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Event Description
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During in-service training the customer reported that the auto button on the cs100 intra-aortic balloon pump (iabp) did not work.There was no patient involvement or adverse event reported.
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Search Alerts/Recalls
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