FDA Adverse Event
Malfunction
Summary report: N
LITHOLYME
MDR report key: 23560519
·
Received November 14, 2025
Report
- Report Number
- 1924066-2025-00082
- Event Type
- Malfunction
- Date Received
- November 14, 2025
- Date of Event
- October 24, 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
- ID, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
DURING A PROCEDURE, THE LITHOLYME CO2 ABSORBENT CANISTER FAILED TO SEAL PROPERLY IN THE ANESTHESIA MACHINE. THE CLINICAL STAFF MANUALLY BAGGED THE PATIENT TO MAINTAIN VENTILATION. NO PATIENT HARM OCCURRED. THE DEVICE HAS NOT BEEN RETURNED FOR PROPER INVESTIGATION.
Description of Event or Problem · 0
CUSTOMER STATED : CANISTER WAS NOT SEALING PROPERLY TO THE POINT THEY NEEDED 2 OF THEM BECAUSE OF THE SEAL AND THEY ULTIMATELY ENDED UP HAVING TO BAG THE PATIENT .LOT NUMBER FOR THIS INCIDENT IS LA24625.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2790120 | LITHOLYME | LITHOLYME, GE MULTI-STYLE CARTRIDGE | CBL | ALLIED MEDICAL LLC. | 55-01-0017 | LA24625 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |