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	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker evaluated the returned product at the product analysis center (pac) and was able to verify the reported issue.The cause of the reported issue was determined to be a corrupted memory (eeprom) of the electrode tray.The customer received a replacement electrode tray.The electrode tray was archived by stryker.Due to character limitations section e1, initial reporter phone, was left blank.The initial reporter¿s phone number is (b)(6).
Event or Problem Description
The customer contacted stryker to report that their electrodes were not working.In this state the device may not be able to deliver defibrillation therapy, if needed.There was no patient use associated with the reported event.

• 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 23591258
• Report Number: 0003015876-2025-02419
• Device Sequence Number: 18623055
• Product Code: MKJ
• UDI-Device Identifier: 00883873867808
• UDI-Public: 00883873867808
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/19/2025

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: 2408063692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIFEPAK CR2 DEFIBRILLATOR, MKJ
• Patient Sex: Unknown