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

Model Number X-SERIES

Device Problem Failure to Charge (1085)

Patient Problem Atrial Fibrillation (1729)

Event Date 12/31/2019

Event Type  malfunction  

Event Description

While attempting to synchronized cardiovert the pt, the monitor only charged half way, then gave an error, then dumped the charge.This occurred twice.Battery was found to have two green dots.Battery was replaced (hot swap), and synchronized shock was charged and delivered on the third attempt.

• Brand Name: ZOLL
• Type of Device: ZOLL X-SERIES
• Manufacturer (Section D): ZOLL MEDICAL CORP. ; chelmsford MA
• MDR Report Key: 9586956
• MDR Text Key: 175376669
• Report Number: 9586956
• 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: 01/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: X-SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2020
• Distributor Facility Aware Date: 12/31/2019
• Event Location: Home
• Date Report to Manufacturer: 01/02/2020
• 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: 63 YR
• Patient Weight: 100