MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL ETCO2 ADAPTER; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	3000-7391
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Etco2 [end tidal carbon dioxide] adapter on code cart failed to zero (attempted twice) sn [redacted].Zoll #3000-7391.

• Brand Name: ZOLL ETCO2 ADAPTER
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 24002695
• Report Number: 24002695
• Device Sequence Number: 12856851
• Product Code: CCK
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/23/2025
• Report Date (Section F): 12/23/2025

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
• Operator of Device: Health Professional
• Device Model Number: 3000-7391
• Device Catalogue Number: 3000-7391
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2026
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/23/2025