MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 EDGE SYSTEM ELECTRODES WITH QUIK-COMBO CONNECTOR AND REDI-PAK¿ PRECONNECT SYSTEM; Electrode, Electrocardiograph

Model Number	35
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section b5, d1, d2a, d4, g4, h4 and h8 have been corrected.
Event or Problem Description
The customer contacted stryker to report that the defibrillation electrodes did not adhere properly to the patient and that the adhesive was weak.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.Stryker continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Event or Problem Description
The customer contacted stryker to report that the defibrillation electrodes did adhere properly to the patient and that the adhesive was weak.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.

• Brand Name: EDGE SYSTEM ELECTRODES WITH QUIK-COMBO CONNECTOR AND REDI-PAK¿ PRECONNECT SYSTEM
• Common Device Name: Electrode, Electrocardiograph
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): Physio-Control, Inc. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: juan salazar ; 11811 willows road ne; redmond, WA 98052 ; +1(425)867-4000
• MDR Report Key: 25027300
• Report Number: 0003015876-2026-00872
• Device Sequence Number: 9991574
• Product Code: MKJ
• UDI-Device Identifier: 00883873784945
• UDI-Public: 00883873784945
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P190007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2026

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: Health Professional
• Device Model Number: 35
• Device Catalogue Number: 70335-000035
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/05/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/06/2026
• Supplement Date Received by Manufacturer: 05/19/2026; 09/02/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/20/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIFEPAK 35 DEFIBRILLATOR/MONITOR, MKJ, SN (B)(6)
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 210 LB