MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL X SERIES DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATOR (NON WEARABLE)

Model Number X SERIES

Device Problems Break (1069); Display or Visual Feedback Problem (1184); Data Problem (3196)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2021

Event Type  malfunction  

Event Description

The usb port on the zoll x-series monitor stopped working.We could no longer transfer to a usb drive or upload monitor configurations to the zoll.It feels like something is loose inside the port.The zoll was taken out of service to have the usb port replaced.Biomed follow up: confirmed the usb connector was broken.Replaced right side panel assy.Tested usb: passed.Performed operational test: passed.Installed bumper to protect damage to usb.

• Brand Name: ZOLL X SERIES DEFIBRILLATOR/MONITOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR (NON WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 11411382
• MDR Text Key: 234668464
• Report Number: 11411382
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/03/2021,03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: X SERIES
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2021
• Device Age: 8 MO
• Event Location: Other
• Date Report to Manufacturer: 03/04/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1