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Model Number N/A |
Device Problem
Noise, Audible (3273)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/30/2019 |
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.A getinge service territory manager (stm) was dispatched to evaluate the iabp and was able to confirm the reported issue.The stm indicated that the compressor motor sounded a bit odd.To address the issue the stm rebuild the compressor with 5000 hour kit.The stm then performed a full calibration and performed all functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.
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Event Description
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It was reported that upon turning on the cs300 intra-aortic balloon pump (iabp) prior to use, an unusual noise was being produced from the motor.There was no patient involvement, thus no adverse event was reported.
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Search Alerts/Recalls
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