MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL X SERIES BATTERY; CARDIAC MONITOR (INCL. CARDIOTACHOMETER AND RATE ALARM)

Model Number X SERIES

Device Problems Failure to Charge (1085); Failure to Deliver Shock/Stimulation (1133)

Patient Problem Cardiac Arrest (1762)

Event Date 12/14/2019

Event Type  Injury  

Event Description

Zoll x series, failed to charge and deliver d-fib with pt under cpr, battery showed 2+ bars.This occurred x2, after 1 successful shock during the treatment of a pt under cardiac arrest.The resuscitation crew successfully administered 1 defib, they continued care.The pt's condition indicated the need for add'l defib.They attempted to charge the unit.The unit displayed charging error or the screen and failed to charge.This was attempted x2, checking the electrodes, cables etc without resolve.The screw replaced the units battery was successfully able to deliver add'l shocks.The pt was transported to a receiving facility but the pt's outcome is unk.

• Brand Name: ZOLL X SERIES BATTERY
• Type of Device: CARDIAC MONITOR (INCL. CARDIOTACHOMETER AND RATE ALARM)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 9519678
• MDR Text Key: 172817223
• Report Number: MW5091883
• Device Sequence Number: 2
• Product Code: DRT
• 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: 12/17/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: X SERIES
• Is the Reporter a Health Professional?: Yes
• 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: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR
• Patient Weight: 84