MalfunctionCBL
MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE
Received Sep 23, 2021 · Event occurred Aug 26, 2021
Report 3002807637-2021-00025 · MDR key 12521895
Device
Generic name
Absorbent, Carbon-dioxide
Model number
MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLECatalog number
8003138
Lot number
L01A-00052
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. AT THIS TIME, 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.
Description of Event or Problem
THE CUSTOMER REPORTED A LEAK ON 8003138 MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE. THERE WAS NO PATIENT HARM REPORTED IN THIS COMPLAINT.