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

Catalog Number	11996-000017
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The customer contacted stryker to report a defibrillation electrode connector pin was bent.The bent pin prohibited the connection between the defibrillator and the defibrillator electrode.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.There was no patient use associated with this event.
Additional Manufacturer Narrative
The customer confirmed that the electrodes were discarded.Therefore, the item was not returned to stryker for evaluation.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report a defibrillation electrode connector pin was bent.The bent pin prohibited the connection between the defibrillator and the defibrillator electrode.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.There was no patient use associated with this event.

• Brand Name: QUIK COMBO
• 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: 23002974
• Report Number: 0003015876-2025-01827
• Device Sequence Number: 21104711
• Product Code: DRX
• UDI-Device Identifier: 00883873784969
• UDI-Public: 00883873784969
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K943301
• 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): 12/31/2025

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: Health Professional
• Device Catalogue Number: 11996-000017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown