FDA Adverse Event
Malfunction
Summary report: N
LITHOLYME
MDR report key: 23560516
·
Received November 14, 2025
Report
- Report Number
- 1924066-2025-00081
- Event Type
- Malfunction
- Date Received
- November 14, 2025
- Date of Event
- October 14, 2025
- Report Date
- November 14, 2025
- Manufacturer
- ALLIED MEDICAL LLC.
- Product Code
- CBL
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DURING A PROCEDURE, THE LITHOLYME CO2 ABSORBENT CANISTER FAILED TO SEAL PROPERLY IN THE ANESTHESIA MACHINE, PREVENTING REGISTRATION OF EXHALED CO2. THE CLINICAL STAFF MANUALLY BAGGED THE PATIENT TO MAINTAIN VENTILATION. NO PATIENT HARM OCCURRED.
Description of Event or Problem · 0
DR. (B)(6) ALSO ATTEMPTED TO INSTALL A CANISTER ON ONE OF OUR MACHINES, BUT IT DID NOT SEAT PROPERLY AND FAILED TO REGISTER CO2 FROM THE PATIENT. THE TEAM HAD TO MANUALLY BAG THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2790117 | LITHOLYME | LITHOLYME, GE MULTI-STYLE CARTRIDGE | CBL | ALLIED MEDICAL LLC. | 55-01-0017 | LA25825A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |