MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION INTELLISENSE ADULT DEFIBRILLATION PADS, POWERHEAR; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	XELAED001B
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
Event or Problem Description
Complainant alleged that during training by facility staff, the device did not detect the attached electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The device was not returned to zoll medical corporation for evaluation.Instead, the data file of the customer's report was provided.Review of the data file did show the error message related to the customer's report.However, without receipt of the device, root cause evaluation could not be performed.Analysis of reports of this type has not identified an increase in trend.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section d4 (primary udi #).The g5 adult pads were returned to zoll medical corporation for evaluation.The customer's report was duplicated and attributed to faulty pads.The pads were scrapped after testing and the customer was sent a replacement set.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: INTELLISENSE ADULT DEFIBRILLATION PADS, POWERHEAR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• 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: 19643811
• Report Number: 2112020-2024-00497
• Device Sequence Number: 20766902
• Product Code: MKJ
• UDI-Device Identifier: 00812394020959
• UDI-Public: (01)00812394020959(17)240728(10)22010701
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2024

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: 07/28/2024
• Device Model Number: XELAED001B
• Device Lot Number: 220107-01
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/29/2024; 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown