Model Number N/A |
Device Problems
Image Display Error/Artifact (1304); Pumping Stopped (1503); Material Integrity Problem (2978); Device Fell (4014)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested with regard to the repair and status of the iabp.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 during use in a patient, while attempting to transport the patient via ambulance, the screen of the cs300 intra-aortic balloon pump (iabp) came loose and fell causing the iabp not to function.Iabp was swapped to continue therapy.There was no harm or injury to patient and no adverse event was reported.
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Manufacturer Narrative
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Getinge service was not requested in connection with this event, but the facility's biomedical engineer advised a representative of our technical support department that the issue was caused by user error.The biomed indicated that when the iabp was removed from the cart, the batteries remained in the cart, and the issue was resolved by placing the batteries back into the iabp.
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Event Description
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It was reported during use in a patient, while attempting to transport the patient via ambulance, the screen of the cs300 intra-aortic balloon pump (iabp) came loose and fell causing the iabp not to function.Iabp was swapped to continue therapy.There was no harm or injury to patient and no adverse event was reported.
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Search Alerts/Recalls
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