MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK-COMBO¿ PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM¿ TECHNOLOGY; EXTERNAL PACING/DEFIBRILLATION/ECG ELECTRODES

Model Number	11996
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.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 failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.Stryker performed a clinical review regarding the reported issue.There is no device data or sufficient reported information to determine device's contribution to the reported outcome.
Event or Problem Description
The customer contacted stryker to report that the electrodes failed to charge or provide defibrillation.This issue is patient-related and a significant delay in therapy was reported.
Event or Problem Description
The customer contacted stryker to report that the electrodes failed to charge or provide defibrillation.This issue is patient-related and a significant delay in therapy was reported.
Additional Manufacturer Narrative
Stryker evaluated the customer¿s device and was unable to verify or duplicate the reported issue.The device passed functional and performance testing and was returned to the customer for use.The cause of the reported issue could not be determined.

• Brand Name: QUIK-COMBO¿ PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM¿ TECHNOLOGY
• Common Device Name: EXTERNAL PACING/DEFIBRILLATION/ECG ELECTRODES
• 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16010206
• Report Number: 0003015876-2022-02721
• Device Sequence Number: 12167396
• Product Code: MLN
• UDI-Device Identifier: 00883873784945
• UDI-Public: 00883873784945
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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 Expiration Date: 10/21/2023
• Device Model Number: 11996
• Device Catalogue Number: 11996-000091
• Device Lot Number: 112386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 03/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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® 15 DEFIBRILLATOR/MONITOR,MKJ, SN (B)(4)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown