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

Catalog Number	11996-000017
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 electrodes failed to provide energy during intervention on a patient.This issue is patient related; however there was no adverse event reported.
Additional Manufacturer Narrative
The faulty electrode was not returned to stryker for investigation.The reported issue was not able to be verified and was not able to be duplicated.A cause of the reported issue could not be determined.
Event or Problem Description
A customer contacted stryker to report that their defibrillation electrodes failed to provide energy during intervention on a patient.This issue is patient related; however there was no adverse event 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: 21803771
• Report Number: 0003015876-2025-00719
• Device Sequence Number: 7568830
• Product Code: DRX
• UDI-Device Identifier: 00883873784969
• UDI-Public: 00883873784969
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K960329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: 331233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 08/29/2025
• 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
• Patient Sex: Unknown