Catalog Number IAP-0700 |
Device Problems
Pressure Problem (3012); Incomplete or Inadequate Connection (4037)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/15/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that the intra-aortic balloon pump (iabp) alarmed for purge failure, high baseline and system error 3 alarms.The field service engineer (fse) serviced the iabp but could not replicate any of the problems and alarms.The fse ran a functional checklist and the iabp performed to specification.There was no report of patient complications, serious injury or death.
|
|
Manufacturer Narrative
|
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iabp multiple alarms is not confirmed.A teleflex field service engineer serviced the pump and could not duplicate the reported alarms.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 reporting complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.
|
|
Event Description
|
It was reported that the intra-aortic balloon pump (iabp) alarmed for purge failure, high baseline and system error 3 alarms.The field service engineer (fse) serviced the iabp but could not replicate any of the problems and alarms.The fse ran a functional checklist and the iabp performed to specification.There was no report of patient complications, serious injury or death.
|
|
Search Alerts/Recalls
|