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 evaluated the electrode pads and the customer's report was not replicated or confirmed.The electrode pads were put through extensive testing use a known good g5 test device without duplicating the report.Visual inspection of the pads observed no damages, were not opened, and are not expired.The pads were scrapped after testing.The customer was sent a set of replacement pads.No trend is associated with reports of this type.
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that during functional testing, the assocated device did not detect the attached electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.

• 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: 20076647
• Report Number: 2112020-2024-00688
• Device Sequence Number: 6537179
• Product Code: MKJ
• UDI-Device Identifier: 00812394020973
• UDI-Public: (01)00812394020973(17)270128(10)24070507
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P160033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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 Model Number: XELAED002B
• Device Lot Number: 240705-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2024
• 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: 08/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2024
• 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