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

Device Problems Failure to Sense (1559); Failure to Calibrate (2440)

Patient Problem Cardiac Arrest (1762)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

Medic 26's etco2 module failed to initialize during a call with a witnessed cardiac arrest.Crew completed call and contacted me.Psm case is created for pso reporting.Etco2 module confirmed after troubleshooting to be nonfunctioning.Monitor id# ar13i005520.

• Brand Name: ETCO2 MODULE
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 15987021
• MDR Text Key: 305527919
• Report Number: MW5113793
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/12/2022

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 Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White