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

Model Number	9355-0307
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Attempted to use the zoll end-tidal co2 monitor during a code blue.However, the device failed to calibrate multiple times despite trying two different cuvettes and were unable to use the etco2 provided on the zoll.Confirmed that the cuvettes being used were compatible with the zoll.Everything else on the zoll was functioning properly during the code blue.

• Brand Name: SENSOR
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 20266999
• Report Number: 20266999
• Device Sequence Number: 17410663
• Product Code: CCK
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/11/2024
• Report Date (Section F): 07/24/2024

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: 9355-0307
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2024
• 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: 07/24/2024