|
Catalog Number IAP-0700 |
Device Problem
Defective Device (2588)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/27/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported "while in or, once the surgeon started to use bovi, lots of arterial pressure interference despite bring in ap trigger on the iabp".To continue therapy, the iabp was switched for another console.No patient injury or consequence reported.The patient's current condition is reported as "fine".
|
|
Manufacturer Narrative
|
Qn#(b)(4).The reported complaint of "arterial pressure interference despite being in ap trigger" is confirmed based on the videos provided by the customer.The videos show an artifact on the arterial pressure waveform and excessive triggering, which was consistent with the reported complaint.No iabp part was returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the abnormal ap trigger.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.
|
|
Event Description
|
It was reported "while in or, once the surgeon started to use bovi, lots of arterial pressure interference despite bring in ap trigger on the iabp".To continue therapy, the iabp was switched for another console.No patient injury or consequence reported.The patient's current condition is reported as "fine".
|
|
Search Alerts/Recalls
|
|
|