MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE
Received Apr 19, 2022 · Event occurred Mar 23, 2022
Report 3002807637-2022-00029 · MDR key 14150760
Device
Generic name
Absorbent, Carbon-dioxide
Manufacturer
Vyaire MedicalModel number
MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLECatalog number
M1173310
Lot number
UNKNOWN
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE CARBON DIOXIDE ABSORBERS ON M1173310 MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE AS IT ABSORBS, IT TURNS PURPLE AND THEY USUALLY LAST UNTIL THE PURPLE REACHES THE BOTTOM AT WHICH POINT THE ANESTHESIA MACHINE WILL ALARM. AT THIS TIME, NO PATIENT INFORMATION REPORTED.
Additional Manufacturer Narrative
VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.