MEDEX LOGICAL PRESSURE MONITORING SYSTEM
Received Feb 24, 2022 · Event occurred Jan 1, 2022
Report 3012307300-2022-04101 · MDR key 13591647
Device
Generic name
Catheter, Pressure Monitoring, Cardiac
Manufacturer
Smiths Medical International, Ltd.Catalog number
MX9624RCZ
Product problems
- Defective Device
- Defective Device
Patient
Unknown
- Respiratory Insufficiency
- Respiratory Insufficiency
Narrative
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.
Additional Manufacturer Narrative
OTHER, OTHER TEXT: THIS MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED AS NO PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DEVICE HISTORY RECORD REVIEW.