Model Number 0998-00-3023-53 |
Device Problem
Failure to Charge (1085)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/09/2022 |
Event Type
malfunction
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Event Description
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It was reported that the cs300 intra-aortic balloon pump (iabp) was not holding the battery 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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A supplemental report will be submitted upon receipt of additional information or completion of our investigation.
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Manufacturer Narrative
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Testing of actual/suspected device|10) a getinge field service engineer (fse) evaluated the iabp unit and found that the batteries were past due for replacement.To fix the issue the fse replaced the batteries and then performed a full pm with calibration, 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 a routine check it was observed that the cs300 intra-aortic balloon pump (iabp) was not holding the battery charge.It is unknown if there was a patient involvement.However, there was no adverse event reported.
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Event Description
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N/a.
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Search Alerts/Recalls
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