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

Catalog Number	11996-000017
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that during a patient event their device was unable to detect the connection of the defibrillation electrodes.Another set of electrodes were used successfully.In this state the device would be inoperable and defibrillation therapy would not be available if needed.This issue is patient related; however, there was no adverse patient outcome reported.
Additional Manufacturer Narrative
In compliance with regulation (eu) 2016/679 of the european parliament and of the council, stryker collects only essential and relevant patient information necessary for regulatory purposes, ensuring that no data capable of identifying a person, directly or indirectly, is gathered.Patient fields in which information is not requested or provided were intentionally left blank.Stryker continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Additional Manufacturer Narrative
Stryker evaluated the returned electrodes and was unable to verify or duplicate the reported issue.The electrodes performed correctly during testing and no damage was observed.The cause of the reported issue could not be conclusively determined.Stryker archived the returned electrodes.
Event or Problem Description
The customer contacted stryker to report that during a patient event their device was unable to detect the connection of the defibrillation electrodes.Another set of electrodes were used successfully.In this state the device would be inoperable and defibrillation therapy would not be available if needed.This issue is patient related; however, there was no adverse patient outcome 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 24304948
• Report Number: 0003015876-2026-00288
• Device Sequence Number: 20162269
• Product Code: MKJ
• UDI-Device Identifier: 00883873784969
• UDI-Public: 00883873784969
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P190007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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 Catalogue Number: 11996-000017
• Device Lot Number: 505257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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