CANNULA SOFT ADULT W/U-CON 7FT TB 50/CS
Received Feb 6, 2023 · Event occurred Jan 12, 2023
Report 8030673-2023-00296 · MDR key 16305622
Device
Generic name
Conserver, Oxygen
Manufacturer
Productos Urologos De Mexico S.a. De C.v.Model number
CANNULA SOFT ADULT W/U-CON 7FT TB 50/CSCatalog number
SFT2699
Lot number
0004232076
Product problems
- Material Deformation
- Material Deformation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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
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
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SFT2699 CANNULA SOFT ADULT W/U-CON 7FT TB 50/CS CANNULA IS LOOPED SO THE PATIENT JUST BREATHES IN THEIR OWN AIR. THERE IS NO INFORMATION ON THE PATIENT OUTCOME.