MAUDE Adverse Event Report: BIO-DETEK INCORPORATED CPR STAT-PADZ; ELECTRODES

Model Number	8900-0402
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	Cardiac Arrest (1762)
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 while attempting to cardiovert a patient (age & gender unknown), an arc was seen from the electrode pads.Complainant indicated that the clinician obtained another device and applied a new set of electrode pads to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The pads were not returned to zoll medical corporation for evaluation; however, log files from the x-series were provided for review.Review of the logs showed that when the shock was delivered it exceeded the expected patient impedance by 75 ohms.Review of the lot history found no issues with cpr stat-padz from lot 4423e.The device history record (dhr) for pads from lot 4423e found that all samples passed in-process testing including impedance testing and the electrical discharge testing.Increased patient impedance can be attributed to multiple factors including insufficient skin preparation, incorrect electrode application/placement, or improper handling of the electrodes.The ifu (aw-2025-07 rev l) for the cpr stat-padz warns the user that excessive hair, poor adherence and/or air under the electrodes, as well as damage/folding in the electrode packaging can lead to the possibility of arcing and skin burns.No trend is associated with reports of this type.

• Brand Name: CPR STAT-PADZ
• Common Device Name: ELECTRODES
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: tina lombari ; 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 20906135
• Report Number: 1218058-2024-00114
• Device Sequence Number: 9181036
• Product Code: MKJ
• UDI-Device Identifier: 00847946016319
• UDI-Public: (01)00847946016319(17)251029(10)4423E
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P160015
• 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): 11/22/2024

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: 10/29/2025
• Device Model Number: 8900-0402
• Device Lot Number: 4423E
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2023
• 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