Catalog Number IAP-0500J |
Device Problem
Power Problem (3010)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the intra-aortic balloon pump (iabp) switched to battery power despite being plugged in while in use.As a result, the iabp was swapped out for another iabp.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).No iabp part was returned to teleflex chelmsford for investigation.The reported complaint of "the iabp was switched to be battery-powered despite it being plugged" is not able to be confirmed.The iabp was tested by a distributor's technician and the issue could not be replicated.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the iap serial and lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
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Event Description
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It was reported that the intra-aortic balloon pump (iabp) switched to battery power despite being plugged in while in use.As a result, the iabp was swapped out for another iabp.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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