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

Catalog Number	11996-000017
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.In compliance with regulation (eu) 2016/679 of the european parliament and of the council, stryker collects only essential and relevant patient information necessary for regulatory purposes, ensuring that no data capable of identifying a person, directly or indirectly, is gathered.Patient fields in which information is not requested or 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.
Event or Problem Description
A customer contacted stryker to report that their defibrillation pads could not detect patient rhythm.In this state, the device may not be able to provide defibrillation therapy, if it were needed.This issue is patient related; however there was no adverse patient outcome reported.
Additional Manufacturer Narrative
The faulty electrodes were not returned to stryker for evaluation.The reported issue was unable to be verified and duplicated and the cause of the reported issue could not be determined.
Event or Problem Description
A customer contacted stryker to report that their defibrillation pads could not detect patient rhythm.In this state, the device may not be able to provide defibrillation therapy, if it were needed.This issue is patient related; however there was no adverse patient outcome reported.

• Brand Name: QUICK 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: 21317962
• Report Number: 0003015876-2025-00240
• Device Sequence Number: 20812034
• Product Code: DRX
• UDI-Device Identifier: 00883873784969
• UDI-Public: 00883873784969
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K960329
• 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): 07/02/2025

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: 319400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 07/02/2025
• 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(R) 15 MONITOR/DEFIBRILLATOR, MKJ
• Patient Sex: Female