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Model Number N/A |
Device Problems
Failure to Charge (1085); Battery Problem (2885)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the iabp and replaced batteries, and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.
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Event Description
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It was reported that during routine check, the cs300 intra-aortic balloon pump (iabp) batteries were not charging.No patient harm, serious injury or adverse event was reported.
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Event Description
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It was reported that during routine check, the cs300 intra-aortic balloon pump (iabp) was not charging the batteries.No patient harm, serious injury or adverse event was reported.
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Manufacturer Narrative
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Updated fields: b4, g3, g6, h2, h6 (health effect - clinical code, type of investigation, component codes, health effect - impact codes), h10, h11.Corrected fields: b5, h6 (medical device - problem code, investigation findings).
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Search Alerts/Recalls
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