MEDISORB EF MULTI-ABSORBER, DISPOSABLE
Received Jun 3, 2021 · Event occurred May 7, 2021
Report 3002807637-2021-00016 · MDR key 11934724
Device
Generic name
Absorbent, Carbon-dioxide
Manufacturer
Vyaire MedicalModel number
MEDISORB¿ EF MULTI-ABSORBER, DISPOSABLECatalog number
M1173311
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 MEDISORB¿ EF MULTI-ABSORBER, DISPOSABLE EXPERIENCED NOT REACHING TARGET VOLUME DURING MECHANICAL VENTILATION DUE TO CRACK THAT CAUSES LEAK OF 10 LPM. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.