Catalog Number IAP-0700 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/24/2018 |
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 by the field service engineer (fse) that the cursor on the intra-aortic balloon pump (iabp) was stuck and would not move.
Issue occurred during use on patient and the pump was swapped out.
The fse could not reproduce the symptom.
The iabp checked out okay.
There was no report of patient harm or injury.
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Manufacturer Narrative
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(b)(4).
Teleflex did not receive the device for investigation.
The reported complaint of "the cursor being stuck" is not able to be confirmed.
The field service agent serviced the pump and no issues was found.
The root cause of the complaint is undetermined.
A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.
The device passed all manufacturing specifications prior to release.
The reported complaint will be monitored for any developing trends.
No further action required at this time.
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Event Description
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It was reported by the field service engineer (fse) that the cursor on the intra-aortic balloon pump (iabp) was stuck and would not move.
Issue occurred during use on patient and the pump was swapped out.
The fse could not reproduce the symptom.
The iabp checked out okay.
There was no report of patient harm or injury.
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Search Alerts/Recalls
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