CANNULA CUSHION INFANT W/7FT TB 50/CS
Received Dec 2, 2020 · Event occurred Nov 6, 2020
Report 8030673-2020-00133 · MDR key 10932129
Device
Generic name
Conserver, Oxygen
Model number
CANNULA CUSHION INFANT W/7FT TB 50/CSCatalog number
002601
Lot number
0004144179
Product problems
- Improper Flow or Infusion
- Improper Flow or Infusion
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
RESULT OF INVESTIGATION: PICTURE AND SAMPLE WERE PROVIDED AND EVALUATED. PERFORMED VISUAL AND FUNCTIONAL TESTS AND NO ISSUES WERE FOUND. THEREFORE THE DEFECT REPORTED BY THE CUSTOMER WAS NOT CONFIRMED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE CANNULA CUSHION INFANT W/7FT TB 50/CS EXPERIENCED LACK OF FLOW. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.