MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 EDGE SYSTEM ELECTRODES WITH QUIK-COMBO CONNECTOR; ELECTRODE, ELECTROCARDIOGRAPH

Catalog Number	11996-000090
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that the electrode could not be plugged in.In this state the device may not be able to deliver defibrillation therapy, if needed.There was no harm to the patient as a result of the reported event.
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Stryker continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Additional Manufacturer Narrative
A stryker service representative performed an initial evaluation of the customer¿s device and observed a physical damage to connector/cable of the electrodes.It was determined that the cause of the issue was deformation in the electrode connector receiver.The customer received replacement electrodes.
Event or Problem Description
The customer contacted stryker to report that the electrode could not be plugged in.In this state the device may not be able to deliver defibrillation therapy, if needed.There was no harm to the patient as a result of the reported event.

• Brand Name: EDGE SYSTEM ELECTRODES WITH QUIK-COMBO CONNECTOR
• 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: 23956188
• Report Number: 0003015876-2026-00009
• Device Sequence Number: 9627195
• Product Code: MKJ
• UDI-Device Identifier: 00883873784938
• UDI-Public: 00883873784938
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190007
• 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): 04/24/2026

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: Health Professional
• Device Catalogue Number: 11996-000090
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MKJ.
• Patient Sex: Unknown