Catalog Number IAP-0500 |
Device Problems
Pressure Problem (3012); Incomplete or Inadequate Connection (4037)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/03/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that the intra-aortic balloon pump (iabp) alarmed for purge failure on start-up therefore the patient was placed on another console without difficulty.There was no report of patient complications, serious injury or death.
|
|
Event Description
|
It was reported that the intra-aortic balloon pump (iabp) alarmed for purge failure on start-up therefore the patient was placed on another console without difficulty.There was no report of patient complications, serious injury or death.
|
|
Manufacturer Narrative
|
(b)(4).No part or recorder strip was returned to teleflex for investigation therefore the reported complaint of the purge failure alarm is not able to be confirmed.The root cause of the complaint is undetermined.If the part is returned or additional information is received at a later day, a full investigation will be completed.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.The reported complaint will be monitored for any developing trends.No further action required at this time.
|
|
Search Alerts/Recalls
|