MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 ELECTRODE-EDGE, ADULT,QCRTS, WORLDWIDE; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number	11996-000090
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
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.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 device pads would not stick to 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.
Event or Problem Description
The customer contacted stryker to report that their device pads would not stick to 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 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.
Additional Manufacturer Narrative
Section d2a of initial medwatch report indicates: electrode, electrocardiograph, multi-function.Section d2a of initial medwatch report should indicate: automated external defibrillators (non-wearable).Section d2b of initial medwatch report indicates: mln.Section d2b of initial medwatch report should indicate: mkj.
Event or Problem Description
The customer contacted stryker to report that their device pads would not stick to 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.
Event or Problem Description
The customer contacted stryker to report that their device pads would not stick to 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
D4 and h4 have been updated with lot number and manufacture date.

• Brand Name: ELECTRODE-EDGE, ADULT,QCRTS, WORLDWIDE
• 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 21507179
• Report Number: 0003015876-2025-00412
• Device Sequence Number: 7974216
• Product Code: MKJ
• UDI-Device Identifier: 00883873784938
• UDI-Public: 00883873784938
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P170018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/04/2026

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: 11996-000090
• Device Lot Number: 411436
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 06/23/2025; 10/01/2025; 04/07/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 07/01/2025; 10/01/2025; 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown