Model Number HEM1 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/30/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The product has not been returned for evaluation.When it arrives and the product evaluation has been completed, a supplemental report will be submitted.The device history record review was completed and all inspections passed with no non-comformances.
|
|
Event Description
|
It was reported that the hem1 will always read co 8 ci 4 sv 80s but the rep has been seeing those numbers cut in half.The rep switched fingers switched hrs and switched pc2ks but was still reading lower co ci sv svi.No other troubleshooting will help.There is no patient injury.There will be no product return but logs have been sent to be analyzed.Patient demographics were requested but unable to be obtained.There was no inappropriate patient treatment administered.
|
|
Manufacturer Narrative
|
A hemisphere monitor and clinical data logs were returned for this complaint.The monitor was run on a known working system for two hours and the values remained stable.No defect was identified during the investigation of the logs and the monitor during product evaluation.The system performed as designed.A pra was opened to address the risk of the allegations of low cardiac index and a capa was opened to facilitate any corrective actions.A potential root cause is a change in algorithm from the ev1000 system to the hemosphere system.It is unknown if user or procedural factors played a role in the allegation of inaccurate values.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
|
|
Manufacturer Narrative
|
Logs were received and analyzed.Although the data appeared to correlate to the event description, the date did not.Additional attempts to clarify the issue are unable to be performed, as the initial reporter is no longer with ew.
|
|
Search Alerts/Recalls
|