MEDEX LOGICAL PRESSURE MONITORING SYSTEM
Received May 11, 2022 · Event occurred Jan 15, 2022
Report 3012307300-2022-08578 · MDR key 14365170
Device
Generic name
Pressure Monitoring (air/gas) Kit
Manufacturer
Smiths Medical International, Ltd.Catalog number
MX960P1CZ
Lot number
4227294
Product problems
- High Readings
- Low Readings
- High Readings
- Low Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE MONITOR READING DIFFER BETWEEN N1BP AND 1BP IS OUT OF RANGE. IBP VALUE IS DIFFERENT FORM THE N1BP VALUE.
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL INSPECTION FOUND NO PHYSICAL MARKINGS OR DAMAGE NOTED ON THE RETURNED UNIT. FUNCTIONAL TESTING FOUND THE DEVICE MEETS SPECIFICATIONS. DEVICE PASSED ALL FUNCTIONAL TESTING. NO PROBLEM FOUND. ROOT CAUSE CANNOT BE DETERMINED AS THE SAMPLE WAS SUCCESSFULLY TESTED AND NO DISCREPANCIES WERE DETECTED.