Model Number N/A |
Device Problems
Failure to Power Up (1476); Charging Problem (2892)
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Patient Problems
No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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At this time, the customer has not requested for getinge to evaluate the iabp unit involved in this event.A getinge field service engineer (fse) conversed with the customer and assisted in repairing the unit involved.Additional information is being requested with regard to the repair and status of the iabp unit.A supplemental report will be submitted if this information is provided to us.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) had a charging issue, and no longer turned on.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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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) had a charging issue, and no longer turned on.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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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.The getinge field service engineer (fse) has reported that after conversing with the customer over the phone, it was noted that the iabp unit was not properly seated in the cart.The issue was resolved.H3 other text : not returned to manufacturer.
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Search Alerts/Recalls
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