MEDEX LOGICAL PRESSURE MONITORING SYSTEM
Received Feb 24, 2022 · Event occurred Jan 1, 2022
Report 3012307300-2022-04095 · MDR key 13591523
Device
Generic name
Catheter, Pressure Monitoring, Cardiac
Manufacturer
Smiths Medical International, Ltd.Catalog number
MX9624RCZ
Lot number
4209006
Product problems
- Defective Device
- Defective Device
Patient
61 YR · Unknown
- Respiratory Insufficiency
- Respiratory Insufficiency
Narrative
Description of Event or Problem
IT WAS REPORTED THAT CURVES FLATTEN OUT AFTER A FEW HOURS OF PLACEMENT OF SHORT AND LONG ARTERIAL CATHETERS. THIS HAPPENED WITH 8 PATIENTS.
Additional Manufacturer Narrative
NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION WILL BE REOPENED IF THE PRODUCT IS RECEIVED.
Additional Manufacturer Narrative
NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION WILL BE REOPENED IF THE PRODUCT IS RECEIVED.
Description of Event or Problem
IT WAS REPORTED THAT CURVES FLATTEN OUT AFTER A FEW HOURS OF PLACEMENT OF SHORT AND LONG ARTERIAL CATHETERS. THIS HAPPENED WITH 8 PATIENTS.