LITHOLYME
Received Mar 26, 2026 · Event occurred Jan 29, 2026
Report 1924066-2026-00004 · MDR key 24707078
Device
Generic name
Litholyme, Ge Multi-style Cartridge
Manufacturer
Allied Medical Llc.Model number
55-01-0017Catalog number
55-01-0017
Lot number
N/A
Product problems
- Gas/Air Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO PATIENT HARM OCCURRED; HOWEVER, THE EVENT REQUIRED IMMEDIATE INTERVENTION TO MAINTAIN ADEQUATE VENTILATION. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, PREVENTING FURTHER ANALYSIS OF THE CAUSE.
Description of Event or Problem
WHEN CHANGING THE CO2 ABSORBENT, IT BECOMES DIFFICULT TO SEAL. RESULTS IN A CIRCUIT LEAK. VERY DANGEROUS TO PATIENT. FLOW SENSORS O2 RINGS FELL OUT OF MACHINE ALONG WITH THE ABSORBENT CONTAINERS, CAUSING CRNA TO MANUALLY VENTILATE THE PATIENT UNTIL THE ANES. TECH WAS ABLE TO PUT PART BACK IN.