MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL; X SERIES MONITOR DEFIBRILLATOR

Model Number X-SERIES

Device Problems Failure to Deliver Shock/Stimulation (1133); Defibrillation/Stimulation Problem (1573)

Patient Problems Cardiomyopathy (1764); Cardiopulmonary Arrest (1765); Ventricular Fibrillation (2130)

Event Date 06/30/2016

Event Type  Death  

Event Description

While treating a (b)(6) male in cardiac arrest the lead paramedic attempted to defibrillate the pt and the zoll x series defibrillator (serial # (b)(4)) failed to deliver a 200 joule shock after the shock button was pressed.According to the paramedic the monitor was charged to 200 joules at the time of the shock attempt.The paramedic noticed the monitor screen had a poor to no ecg rhythm and attempted to trouble shoot the cpr stat-padz.The paramedic confirmed the pads were fully adhered to the pt's chest (right anterior/left lateral) position.The paramedic confirmed connection between the therapy cable and the cpr stat-padz cable.The paramedic confirmed connection between the therapy cable and zoll x-series defibrillator.After troubleshooting all three connections the paramedic still could not deliver a shock and disarmed the defibrillator.The paramedic removed the existing cpr stat-padz and applied a new set of cpr stat-padz.The new set of pads did work and the pt subsequently received defibrillations through the new set of pads.

• Brand Name: ZOLL
• Type of Device: X SERIES MONITOR DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824 4105
• MDR Report Key: 5791751
• MDR Text Key: 49516720
• Report Number: 5791751
• Device Sequence Number: 1
• Product Code: MKJ
• 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: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X-SERIES
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2016
• Distributor Facility Aware Date: 06/30/2016
• Device Age: 3 NA
• Event Location: Home
• Date Report to Manufacturer: 07/01/2016
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Weight: 73