MAUDE Adverse Event Report: ZOLL MEDICAL CORP. ZOLL X SERIES; CARDIAC MONITOR

Model Number X SERIES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Loss of consciousness (2418); Loss Of Pulse (2562)

Event Date 05/10/2018

Event Type  Injury  

Event Description

While using a zoll x series monitor on a patient we found to be pulseless and unresponsive the monitor was used and functioned properly with the notable exception of the end tidal capnography.The device was restarted several times in an attempt to correct with no change.Patient had a history of being septic six months prior and autopsy showed an enlarged heart.

• Brand Name: ZOLL X SERIES
• Type of Device: CARDIAC MONITOR
• Manufacturer (Section D): ZOLL MEDICAL CORP.; 269 mill rd. ; chelmsford MA 01824
• MDR Report Key: 7557703
• MDR Text Key: 109758637
• Report Number: MW5077568
• Device Sequence Number: 1
• 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: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X SERIES
• Was Device Available for Evaluation?: Yes
• 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): Other
• Patient Age: 51 YR
• Patient Weight: 82