Catalog Number 684267 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/23/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
The suspect device is expected to return for full evaluation.A follow up will be submitted when the evaluation is complete.
|
|
Event Description
|
The account alleges that during post-op monitoring of a heart surgery patient, the clinical staff believed that the patient developed hypertension due to pressure changes demonstrating r-r variability.The patient was medically treated for hypertension [catapresan iv] with no additional consequences to report.The account alleges that the inaccurate pressure changes may be related to a faulty transducer interface cable.The cable has been tested at another site and the fault was reproducible.
|
|
Manufacturer Narrative
|
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
|
|
Search Alerts/Recalls
|