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

Model Number	55-01-0027
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer has reported leak test, failures, issues requiring intervention mid case at least once.
Additional Manufacturer Narrative
During a procedure, the co2 absorbent canister failed and required intervention.No patient harm occurred.The device has not been returned for proper investigation.

• Brand Name: CARBOLIME
• Common Device Name: CARBOLIME, GE MULTI-STYLE CARTRIDGE
• Manufacturer (Section D): ALLIED MEDICAL LLC.; 13622 lakefront drive; earth city MO 63045
• 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: 23560517
• Report Number: 1924066-2025-00083
• Device Sequence Number: 21365527
• Product Code: CBL
• UDI-Device Identifier: 00026072025321
• UDI-Public: 00026072025321
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

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: 55-01-0027
• Device Catalogue Number: 55-01-0027
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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