MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION INTELLISENSE ADULT DEFIBRILLATION PADS,CPR DEVICE; ELECTRODES

Model Number	XELAED002B
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that during biomed testing, the associated defibrillator did not detect these attached electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
This supplemental medwatch reports the evaluation of the device.This supplemental medwatch report also corrects information submitted in the initial medwatch report.Please reference sections d1 updated, d4 catalog number removed, d4 primary udi number updated.The g5 electrodes were not received at zoll medical corporation for evaluation.The log file from the device being used at the time of the failures was provided for review.The customer's report was observed during review of the device data logs.A higher resistance has been observed during an evaluation of other sets of the same lot.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: INTELLISENSE ADULT DEFIBRILLATION PADS,CPR DEVICE
• Common Device Name: 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: 19308593
• Report Number: 2112020-2024-00365
• Device Sequence Number: 20643990
• Product Code: MKJ
• UDI-Device Identifier: 00812394020973
• UDI-Public: (01)00812394020973(17)09282025(10)23032107
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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
• Operator of Device: Other
• Device Expiration Date: 09/21/2025
• Device Model Number: XELAED002B
• Device Catalogue Number: XELAED002B
• Device Lot Number: 230321-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown