Model Number 0998-00-0800-53 |
Device Problem
Charging Problem (2892)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device : a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and determined that the batteries were not charging due to the failed power management board.The fse resolved the issue by replacing the power management board and confirmed that the batteries charged as required.The fse performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.
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Event Description
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It was reported that during patient use, the cardiosave intra-aortic balloon pump (iabp) battery would not hold charge.No patient harm, serious injury or adverse event was reported.
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Event Description
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It was reported that the battery of the cardiosave intra-aortic balloon pump (iabp) would not hold charge.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4, b5, e1(email), g4, g7, h2, h6, h10, h11.Corrected fields: g3.
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Manufacturer Narrative
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H2(reported in follow-up 1 was submitted incorrectly, correction should have been selected).
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Event Description
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N/a.
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Search Alerts/Recalls
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