|
Model Number IPN001112 |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/30/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported the intra-aortic balloon pump (iabp) touchscreen froze as the staff was connecting the iabp to the patient.As a result, the staff cycled the power and was able to correct the issue, however the staff swapped out the iabp.There was no report of patient complications, serious injury or death.
|
|
Manufacturer Narrative
|
(b)(4).No iabp part was returned to teleflex chelmsford for investigation.The reported complaint of the display screen freeze up is not able to be confirmed.The field service engineer checked the pump and could not replicate the problem.The pump passed functional checkout.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 revived risk.This will be monitored for any developing trends.
|
|
Event Description
|
It was reported the intra-aortic balloon pump (iabp) touchscreen froze as the staff was connecting the iabp to the patient.As a result, the staff cycled the power and was able to correct the issue, however the staff swapped out the iabp.There was no report of patient complications, serious injury or death.
|
|
Search Alerts/Recalls
|
|
|