MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL; ZOLL X-SERIES

Model Number X-SERIES

Device Problem Charging Problem (2892)

Patient Problems Cardiac Arrest (1762); Cardiac Arrest (1762); Death (1802); Sudden Cardiac Death (2510)

Event Date 12/09/2019

Event Type  Death  

Event Description

While transporting a pt in an ambulance, the pt went into a lethal arrhythmia (ventricular fibrillation).The attending paramedic attempted to charge the zoll x-series monitor four times and all on all four charges, the monitor did not completely charge and automatically aborted the charging.After the fourth attempt the crew turned the monitor off then back on and it appeared to completely charge 5 times.During this same event, the monitor successfully charged and defibrillated the pt 3 times.According to the physician at the receiving hosp, the pt expired.

• Brand Name: ZOLL
• Type of Device: ZOLL X-SERIES
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION ; chelmsford MA
• MDR Report Key: 9491245
• MDR Text Key: 241260793
• Report Number: 9491245
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: X-SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2019
• Distributor Facility Aware Date: 12/10/2019
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 12/10/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Death
• Patient Age: 56 YR
• Patient Weight: 100