MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION ELECTRODES W/CPRD, ADULT, G5 AED (CS)

Model Number	XELAED002B
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that during functional testing, the associated defibrillator failed impedance testing using these attached electrodes.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The electrodes were not returned to zoll medical corporation for evaluation; the customer provided the device history log for review.The customer's report was observed during the review of device data logs.However, without the device or the electrode pads root cause analysis could not be performed.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES W/CPRD, ADULT, G5 AED (CS)
• 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: 17816931
• Report Number: 2112020-2023-00837
• Device Sequence Number: 16729972
• Product Code: MKJ
• UDI-Device Identifier: 00812394020973
• UDI-Public: 00812394020973
• Combination Product (Y/N): N
• Initial Reporter Country: NP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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
• Operator of Device: Other
• Device Expiration Date: 10/28/2025
• Device Model Number: XELAED002B
• Device Catalogue Number: XELAED002B
• Device Lot Number: 230414-09
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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