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

Model Number	8900-0402
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the pads were damaged during opening/removal of packaging.Complainant indicated that the clinician obtained another set of pads to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The electrodes were returned to zoll medical corporation for evaluation.The returned cpr stat-padz were received with eletrodes properly placed on the release-coated styrene.Upon removal and visual inspection, the sternum pad showed gel peeling in one corner, exposing the tin beneath.Evaluation of retain samples from lot 3924d showed no issues in continuity or adhesion, and dhr review revealed no discrepancies related to gel rolling or peeling.Gel peeling may result from factors such as pads sticking to the styrene or improper electrode removal.The ifu for cpr stat-padz (aw-r2025-07 rev l) instructs the user to grasp the electrode at the red tab and peel away the plastic liner.No trend is associated with reports of this type.
Additional Manufacturer Narrative
Additional information: this mdr was submitted after a retrospective review of complaints associated with capa-183.The submission was late because the mdr reports were incorrectly categorized as "not reportable" due to a misapplication of reporting criteria.This application stemmed from training, lack of clarity in procedural guidance, and inconsistent use of decision-making tools to ensure accurate classification.

• Brand Name: CPR STAT-PADZ
• Common Device Name: PACING 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: 23350908
• Report Number: 1218058-2025-00164
• Device Sequence Number: 9076296
• Product Code: MKJ
• UDI-Device Identifier: 00847946016319
• UDI-Public: (01)00847946016319(17)260924(10)3924D
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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 Expiration Date: 09/24/2026
• Device Model Number: 8900-0402
• Device Lot Number: 3924D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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