MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE
Received Sep 15, 2021 · Event occurred Aug 2, 2021
Report 3002807637-2021-00024 · MDR key 12475903
Device
Generic name
Absorbent, Carbon-dioxide
Model number
MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLECatalog number
M1173310
Lot number
LO3A-1219
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO SAMPLE NOR PICTURES AVAILABLE FOR EVALUATION. THE CUSTOMER STATED THAT THE SAMPLE WAS DISCARDED. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. 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¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE EXPERIENCED LOSS OF MECHANICAL VENTILATION DURING A CASE. AS AN INTERVENTION, THEY MANUALLY VENTILATED THE PATIENT WHILE THEY SWAPPED THE MACHINE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.