Catalog Number 0998-00-3023-53 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/12/2017 |
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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The customer reported that while in use on a patient, the intra-aortic balloon pump (iabp) stopped working.The iabp did not turn off, but it stopped working.The customer had no patient details.However, there was no patient injury or adverse event reported.
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Manufacturer Narrative
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07/26/2017 03:05 pm (gmt-4:00) added by (b)(6)(b)(6):
the service territory manager (stm) could not duplicate the alleged malfunction.Both the alarm and failure logs were checked and the intra-aortic balloon pump (iabp) was run without any issues.Functionality checks were performed to factory specifications.The iabp was returned back to clinical use upon completion.The stm also replaced the following broken, non-critical parts due to their cosmetic appearance: the iv bracket, the iv shaft fasten and the helium tank valve knob parts.
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Event Description
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The customer reported that while in use on a patient, the intra-aortic balloon pump (iabp) stopped working.The iabp did not turn off, but it stopped working.The customer had no patient details.However, there was no patient injury or adverse event reported.
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Search Alerts/Recalls
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