MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK-STEP PACING/ECG/DEFIBRILLATION ELECTRODES; Automated External Defibrillators (Non-Wearable)

Catalog Number	11101-000021
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer will be provided with replacement electrodes.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
A customer contacted stryker to report that the electrodes connected to their device were not being recognized.Another set of electrodes were available and were used; the device recognized them and connected correctly.There was no patient use associated with the reported issue.

• Brand Name: QUIK-STEP PACING/ECG/DEFIBRILLATION ELECTRODES
• Common Device Name: Automated External Defibrillators (Non-Wearable)
• 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: 24852354
• Report Number: 0003015876-2026-00758
• Device Sequence Number: 12175270
• Product Code: MKJ
• UDI-Device Identifier: 00883873867808
• UDI-Public: 00883873867808
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 08/14/2026

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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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