Catalog Number IAP-0500 |
Device Problems
Increase in Pressure (1491); Incomplete or Inadequate Connection (4037)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/01/2019 |
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 when preparing the patient for transport the intra-aortic balloon pump (iabp) had recurrent purge failure alarms and high baseline alarms.The issue was resolved by switching to another console.There was no report of patient injury or consequence.
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Event Description
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It was reported that when preparing the patient for transport the intra-aortic balloon pump (iabp) had recurrent purge failure alarms and high baseline alarms.The issue was resolved by switching to another console.There was no report of patient injury or consequence.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of "purge failure and high baseline alarm" was confirmed by the field service engineer; however, the returned pcs assembly passed visual and functional test specifications during the complaint investigation.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.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.
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Search Alerts/Recalls
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