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 01/28/2022 |
Event Type
malfunction
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) despite being plugged was unable to charge the batteries, and was getting an error code of "battery not detected" displayed on the console.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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Device not accessible for testing: at this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested from the customer with regard to the repair and status of the iabp.A supplemental report will be submitted when additional information is provided.
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Manufacturer Narrative
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The iabp is reported to be back in service.Additional information has been requested.A supplemental report will be submitted upon completion of our investigation.Patient height: 170cm.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) despite being plugged was unable to charge the batteries, and was getting an error code of "battery not detected" displayed on the console.It is unknown under which circumstances this occurred; however there was no harm or injury to patient and no adverse event was reported.
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Manufacturer Narrative
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Back in clinical use, but awaiting on the ge technician for repair and explanation on how it was cleared for clinical use.
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Event Description
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N/a.
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Search Alerts/Recalls
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