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

Model Number	8900-0400
Medical Device Problem Code	Patient Device Interaction Problem (4001)
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 device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the electrodes would not adhere to the patient's skin.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
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 lot #, expiration date and udi#.The device was returned to zoll medical corporation for evaluation.Two unopened boxes of electrodes from the same lot (lot# 3125j) were received for evaluation; however, the pads used during the reported patient event were not returned.Retained sample testing was performed.Visual inspection confirmed acceptable gel condition with no drying or rolling observed.Functional testing using a known good device and simulator demonstrated all pads delivered appropriate energy range.An 8-hour wear study showed normal adhesion performance, with expected minor adhesive residue upon removal.The absence of gel/adhesive residue remaining on the patient upon removal of the electrodes does not impact the efficacy of the electrodes.Based on evaluation results, no functional issues or performance deficiencies were identified.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: CPR STAT PADZ
• Common Device Name: ELECTRODE
• 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: 23973915
• Report Number: 1218058-2026-00001
• Device Sequence Number: 17340046
• Product Code: MKJ
• UDI-Device Identifier: 10847946016316
• UDI-Public: (01)10847946016316(17)270730(10)3125J
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160022
• 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): 12/16/2025

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: 8900-0400
• Device Lot Number: 3125J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2025
• 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