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Catalog Number IAP-0700 |
Device Problems
Signal Artifact/Noise (1036); Image Display Error/Artifact (1304); Incorrect Measurement (1383)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/26/2019 |
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) compared to the wall monitor was triple counting the r wave before patient prepping, for example, wall monitor reads 60, iabp reads 170, and balloon inflated/deflated accordingly (at that time, patient electrocardiogram leads had all been removed and the console was slaved off the wall monitor).The perfusionist plug and unplug the slave cable, unable to solve the problem; then switched from 1:1 to 1:2, still working at 1:1.The perfusionist swapped out the console.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.
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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 triggered ap was able to be confirmed by the customer photo.The field service engineer serviced the pump and could not confirm the triggering difficulty.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the 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 revised risks.The reported complaint 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) compared to the wall monitor was triple counting the r wave before patient prepping, for example, wall monitor reads 60, iabp reads 170, and balloon inflated/deflated accordingly (at that time, patient electrocardiogram leads had all been removed and the console was slaved off the wall monitor).The perfusionist plug and unplug the slave cable, unable to solve the problem; then switched from 1:1 to 1:2, still working at 1:1.The perfusionist swapped out the console.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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