|
Model Number 2110 |
Device Problem
Device Alarm System (1012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/01/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that the device had a downstream occlusion calibration failure.The fault occurred during testing, there was no patient involvement.
|
|
Manufacturer Narrative
|
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.B3: unknown.
|
|
Manufacturer Narrative
|
One device was received for evaluation.Visual inspection found a bubbled dso seal, damaged uso seal, and a scratched lcd lens.There was no evidence found in the event history log.Functional testing was able to duplicate the reported problem.It was determined that the dso sensor was the root cause and was replaced.The service history review had no indication that the complaint was related to a service of the device within the review period.
|
|
Search Alerts/Recalls
|
|
|