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

Model Number XELAED001B

Device Problems High impedance (1291); Unable to Obtain Readings (1516)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that during training by facility staff, the associated defibrillator displayed an "ecg fault -501 error"message, fails for high impedance, and does not detect these attached electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The device and electrode pads were not returned to zoll medical corporation for evaluation.The customer's report was observed by a zoll approved service provider.The report was attributed to the electrode pads, once replaced the device performed to specifications.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ADULT, G5 AED
• Type of Device: ELECTRODE
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• MDR Report Key: 12469429
• MDR Text Key: 272297295
• Report Number: 2112020-2021-00889
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00812394020959
• UDI-Public: 00812394020959
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/28/2023
• Device Model Number: XELAED001B
• Device Catalogue Number: XELAED001B
• Device Lot Number: 210204-04
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1