MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK-STEP; ELECTRODE, ELECTROCARDIOGRAPH, MULTI-FUNCTION

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	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
The customer contacted stryker to report that their electrodes were not working with the device.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
Event or Problem Description
The customer contacted stryker to report that their electrodes were not working with the device.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
The device has not been returned to stryker for evaluation.The reported issue could not be verified or duplicated and the cause of the reported issue could not be determined.The customer was provided with a replacement electrodes to resolve the issue.

• Brand Name: QUIK-STEP
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH, MULTI-FUNCTION
• 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: 22191854
• Report Number: 0003015876-2025-01201
• Device Sequence Number: 18448533
• Product Code: DRX
• 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,Followup
• Report Date (Section B): 10/20/2025

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: 240429-3698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 10/20/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIFEPAK CR2 DEFIBRILLATOR, MKJ, SN (B)(6)
• Patient Sex: Unknown