MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK-COMBO ELECTRODES WITH REDI-PAK PRECONNECT SYSTEM; ELECTRODE, ELECTROCARDIOGRAPH, MULTI-FUNCTION

Catalog Number	11996-000017
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The saskatchewan health authority contacted stryker to report that a hospital reported the quick combo pads burned a patient's chest.
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.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.
Additional Manufacturer Narrative
Additional information: the customer declined to return the quik combo electrodes to stryker for evaluation.As such, the reported issue could not be verified or duplicated and a conclusive root cause of the reported issue could not be determined.Customer confirmed a second degree burn with minor first aid to treat burn.
Event or Problem Description
The saskatchewan health authority contacted stryker to report that a hospital reported the quick combo pads burned a patient's chest.

• Brand Name: QUIK-COMBO ELECTRODES WITH REDI-PAK PRECONNECT SYSTEM
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH, MULTI-FUNCTION
• 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: 21810814
• Report Number: 0003015876-2025-00726
• Device Sequence Number: 7328900
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 11996-000017
• Device Lot Number: 420194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 07/07/2025
• 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: UNKNOWN STRYKER REDMOND PRODUCT.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown