Catalog Number 0684-00-0604 |
Device Problems
Optical Problem (3001); Pressure Problem (3012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/19/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that during intra-aortic balloon (iab) therapy, the console generated a fiber optic sensor failure alarm and the arterial pressure was not displayed.An alternative radial source was used to monitor the arterial pressure.There was no patient harm or adverse event reported.
|
|
Manufacturer Narrative
|
Event site postal code: (b)(6).The device will not be 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).
|
|
Manufacturer Narrative
|
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period nov-19 through oct-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint (b)(4).
|
|
Search Alerts/Recalls
|