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

Catalog Number	11403-000002
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that the electrodes of their device would not work.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
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: Electrodes, 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: 50432790
• Report Number: 0003015876-2026-01700
• Device Sequence Number: 10418201
• Product Code: MKJ
• UDI-Device Identifier: 00883873824597
• UDI-Public: 00883873824597
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 08/25/2026

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: 11403-000002
• Device Lot Number: 523028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/25/2026
• 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