Model Number IPN000320 |
Device Problem
Failure to Run on Battery (1466)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/11/2020 |
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) powered off as soon as the user unplugged it from ac power at the bedside to begin transport.As a result, the iabp was swapped out with the hospital's iabp.There was no report of patient complications or injury.
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Event Description
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It was reported that the intra-aortic balloon pump (iabp) powered off as soon as the user unplugged it from ac power at the bedside to begin transport.As a result, the iabp was swapped out with the hospital's iabp.There was no report of patient complications or injury.
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Manufacturer Narrative
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Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of "pump powered off when the user unplugged it from ac power" is not confirmed.The returned power supply passed visual and functional test specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was not performed.There was no confirmed product failure with the returned sample.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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Search Alerts/Recalls
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