Catalog Number 0684-00-0474 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Death (1802)
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Event Date 07/24/2020 |
Event Type
Death
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Manufacturer Narrative
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The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
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Event Description
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It was reported during intra-aortic balloon(iab) therapy, the console generated maintenance code 35 may be required alarm.After the machine alarmed, the customer replaced the standby machine.The patient's condition was stable for a while, and subsequently patient eventually died, the cause is unknown.There was no reported malfunction on the intra-aortic balloon(iab).A separate report will be submitted for the iabp involved.
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Event Description
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It was reported during intra-aortic balloon(iab) therapy, the console generated maintenance code 35 may be required alarm.After the machine alarmed, the customer replaced the standby machine.The patient's condition was stable for a while, and subsequently patient eventually died, the cause is unknown.There was no reported malfunction on the intra-aortic balloon(iab).A separate report will be submitted for the iabp involved.
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Manufacturer Narrative
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Additional information: udi number: (b)(4).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Reference complaint #(b)(4).
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Search Alerts/Recalls
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