MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION ELECTRODES, ADULT, G5 AED

Model Number XELAED001B

Device Problem High impedance (1291)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Complainant alleged that during biomed testing, the associated device failed for high impedance using these electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Manufacturer Narrative

The adult g5 electrode pads were returned to zoll medical corporation; the customer's report was duplicated and attributed to a faulty electrodes.The adult g5 electrode pads were replaced to resolve the report.Analysis for reports of this type has not identified an increase in trend.This report was inadvertently submitted.Reports of this nature have no potential for clinical impact.

• Brand Name: ELECTRODES, ADULT, G5 AED
• Type of Device: ELECTRODES
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 18169820
• MDR Text Key: 328535043
• Report Number: 2112020-2023-01057
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00812394020959
• UDI-Public: 00812394020959
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

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: XELAED001B
• Device Catalogue Number: XELAED001B
• Device Lot Number: 230309-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1