Model Number 0684-00-0576-01 |
Device Problem
Optical Problem (3001)
|
Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/15/2022 |
Event Type
Death
|
Manufacturer Narrative
|
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).Device not returned.
|
|
Event Description
|
It was reported that shortly after inserting the intra-aortic balloon (iab), the console generated a fiber optic sensor failure message.The customer was able to connect and successfully transduce the central lumen for an arterial line prior to our call back.They were advised in possible causes for the message such as damage to the sensor, or wetness at the connection during setup.At that time, the patient was stable and being transferred to the icu.There was no patient harm or adverse event reported.
|
|
Manufacturer Narrative
|
Additional updated information: complete initial reporter name - (b)(6).Adverse event or product problem, outcome attributed to ae, describe event or problem , device available for eval?, initial reporter, type of reportable event, health effect ¿ clinical code, health effect ¿ impact codes.The device was not returned and could not be evaluated.It was not saved by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id # (b)(4).
|
|
Event Description
|
It was reported that shortly after inserting the intra-aortic balloon (iab), the console generated a fiber optic sensor failure message.The customer was able to connect and successfully transduce the central lumen for an arterial line prior to our call back.They were advised in possible causes for the message such as damage to the sensor, or wetness at the connection during setup.At that time, the patient was stable and being transferred to the icu.It was later reported that the patient did not survive and iab was not saved.
|
|
Manufacturer Narrative
|
Updated fields - event site email, describe event or problem.Complaint record id # (b)(4).
|
|
Event Description
|
It was reported that immediately after inserting the intra-aortic balloon (iab), the console generated a fiber optic sensor failure message.The fiber optic did not work from the onset of plugging it in.Therapy was started by unplugging the fiber optics and were using ecg trigger.The customer was able to connect and successfully transduce the central lumen for an arterial line prior to our call back.They were advised in possible causes for the message such as damage to the sensor, or wetness at the connection during setup.At that time, the patient was stable and being transferred to the icu.It was later reported that the patient did not survive and iab was not saved.
|
|
Event Description
|
N/a.
|
|
Manufacturer Narrative
|
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).
|
|
Search Alerts/Recalls
|