MEDISORB LOOSE FILL TWINPACK 4.5 KG (9.9 LB.), DISPOSABLE
Received Nov 26, 2020 · Event occurred Jun 1, 2020
Report 3002807637-2020-00009 · MDR key 10909216
Device
Generic name
Absorbent, Carbon-dioxide
Manufacturer
Vyaire MedicalCatalog number
8570043
Lot number
8710319
Product problems
- Crack
- Crack
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DEVICE EVALUATION: D9, G3, G6, H2, H3, H6 AND H10 H10: VYAIRE MEDICAL RECEIVED THE DEVICE AND PERFORMED AN EVALUATION. HOWEVER, THE REPORTED ISSUE WAS NOT REPRODUCIBLE. VYAIRE MEDICAL ENSURED ALL COMPONENTS ARE UP TO DATE AND CONTINUED PER SERVICE PROCESSING PROCEDURE. THE SUSPECT DEVICE/COMPONENT PASSED ALL TESTING AND MET ALL SPECIFICATIONS.
Additional Manufacturer Narrative
AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED YET.
Description of Event or Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE NEW SODA LIME CANISTER WAS EXHAUSTED WHILE CONNECTED TO AN ANIMAL PATIENT AT A VETERINARY PRACTICE. THERE WAS NO HARM ASSOCIATED WITH THE EVENT AS THE DEFECTIVE MEDISORB WAS REPLACED WITH THE BACKUP UNIT.