MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL X-SERIES ADVANCED; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number ZOLL X-SERIES ADVANCED CARDIAC M

Patient Problem Cardiac Arrest (1762)

Event Date 03/25/2024

Event Type  Death  

Event Description

We are a fire based ems (emergency medical systems) service using the zoll x-series advanced cardiac monitor.While treating a patient in cardiac arrest a defibrillation was delivered.At the next pulse check the monitor showed a lead fault and no ekg(electrocardiogram) activity on the screen.It was quickly determined that there was an issue with the monitor that was preventing the crew from seeing the patients ekg.Since they were not able to see the ekg, this may have prevented them from delivering a subsequent defibrillation in a timely manner.There was another monitor available in another unit that was on scene.This monitor was retrieved and used in place of the first one.There were no further issues in the resuscitation with the use of the second monitor.A new cable for the limb leads was installed at the station after the incident, but that did not fix the problem.The monitor was kept out of service and a service call was placed for the cardiac monitor.Pt deceased.The patient was in cardiac arrest, and was later declared deceased at the hospital.It would be impossible to attribute this outcome solely to this cable failure, but its failure did inhibit timely care, and may have prevented a subsequent defibrillation from being delivered.

• Brand Name: ZOLL X-SERIES ADVANCED
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 19181100
• MDR Text Key: 341051243
• Report Number: MW5154255
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2024

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
• Device Operator: Health Professional
• Device Model Number: ZOLL X-SERIES ADVANCED CARDIAC M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian