MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK-STEP¿ PACING/ECG/DEFIBRILLATION ELECTRODES; EXTERNAL DEFIBRILLATOR ELECTRODE, ADULT, SINGLE-USE

Model Number	CR2
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device's electrodes would not recognize the patient.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
The customer received a replacement device and the original device was sent to the depot for evaluation.Stryker evaluated the customer's device and verified the reported issue.The white backing of the electrode tray was still attached to the removed electrode pads, indicating that the user attempted to remove the electrode pads by pulling on the white plastic backing.If the red loops on the electrode pads are pulled to remove the plastic backing as instructed in the lpcr2 operating instructions, the plastic backing remains adhered to the plastic tray.The root cause of the issue reported issue was user error.The device was archived by stryker 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.

• Brand Name: QUIK-STEP¿ PACING/ECG/DEFIBRILLATION ELECTRODES
• Common Device Name: EXTERNAL DEFIBRILLATOR ELECTRODE, ADULT, SINGLE-USE
• 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: 24240508
• Report Number: 0003015876-2026-00232
• Device Sequence Number: 9184092
• Product Code: MKJ
• UDI-Device Identifier: 00883873871577
• UDI-Public: 00883873871577
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P170018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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 Model Number: CR2
• Device Catalogue Number: 99512-001261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2023
• 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 Age: 14 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic