Model Number 0998-00-0800-53 |
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 05/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) would not charge the battery.Additionally, the power cord would not retract.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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Additional information is being requested with regard to the repair and status of the iabp.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 the cardiosave intra-aortic balloon pump (iabp) would not charge the battery.Additionally, the power cord would not retract.It is unknown the circumstances under which the event occurred; however there was no patient involvement and no adverse event was reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the iabp and was unable to reproduce the reported issue.The fse reconnected ac power cord and power supply connectors, reassembled unit, and the batteries were charging.Allowed device to run until batteries were depleted and recharged the batteries.No other issues noted.Pm was performed during the same service visit.Full calibration, functional, and safety checks were performed which passed to meet 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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N/a.
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Search Alerts/Recalls
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