MAUDE Adverse Event Report: ALLIED MEDICAL LLC. LITHOLYME; LITHOLYME, GE MULTI-STYLE CARTRIDGE

Model Number	55-01-0017
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
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.

• Brand Name: LITHOLYME
• Common Device Name: LITHOLYME, GE MULTI-STYLE CARTRIDGE
• Manufacturer (Section D): ALLIED MEDICAL LLC.; 46 new street; stuyvesant falls NY 12174
• Manufacturer (Section G): ALLIED MEDICAL LLC; 46 new street; stuyvesant falls NY 12174
• Manufacturer Contact: nicole szakats ; 13622 lakefront drive; earth city, MO 63045 ; 3147712400
• MDR Report Key: 24707078
• Report Number: 1924066-2026-00004
• Device Sequence Number: 10046408
• Product Code: CBL
• UDI-Device Identifier: 00026072025260
• UDI-Public: (01)00026072025260
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 55-01-0017
• Device Catalogue Number: 55-01-0017
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown