MAUDE Adverse Event Report: Physio-Control, Inc. - 3015876 QUIK-STEP¿ pacing/ECG/defibrillation electrodes; Electrode, Electrocardiograph

Catalog Number	11101-000021
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that during a patient event the defibrillation electrodes on their device would not adhere properly to the patient and did not function with the device.Another set of electrodes were used.As a result defibrillation therapy may be delayed or 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.

• Brand Name: QUIK-STEP¿ pacing/ECG/defibrillation electrodes
• 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: 50791656
• Report Number: 0003015876-2026-01862
• Device Sequence Number: 9416084
• Product Code: MKJ
• UDI-Device Identifier: 00883873867808
• UDI-Public: 00883873867808
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P170018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: Lay User/Patient
• Device Catalogue Number: 11101-000021
• Device Lot Number: 2508193695
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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