Catalog Number 0998-00-3023-53 |
Device Problem
Failure of Device to Self-Test (2937)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The initial reporter named in block is a getinge employee who has different contact details from that of the event site, and has the following contact information: (b)(6).(b)(4).The getinge stm replaced the batteries along with the front door grommet and concealment labels.The stm then completed the pm with safety, calibration and functionality checks.The iabp passed all tests to factory specifications and was returned to the customer for clinical use.
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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) failed the battery run time test during a preventative maintenance (pm) performed by a getinge service territory manager (stm).There was no patient involvement and no adverse event was reported.
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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 getinge 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 the cs300 intra-aortic balloon pump (iabp) failed the battery run time test during a preventative maintenance (pm) performed by a getinge service territory manager (stm).There was no patient involvement and no adverse event was reported.
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Search Alerts/Recalls
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