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

Model Number	11996
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
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.
Event or Problem Description
The customer contacted stryker to report that the electrode did not hold a charge.In this state, the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.
Additional Manufacturer Narrative
The device was not returned to stryker for evaluation.Stryker has made multiple attempts to contact the customer regarding the status of their device, but no response has been received from the customer.The cause of the reported issue could not be determined.H3 other text : device not return.
Event or Problem Description
The customer contacted stryker to report that the electrode did not hold a charge.In this state, the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.

• Brand Name: QUIK-COMBO¿ PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM¿ TECHNOLOGY
• 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16376817
• Report Number: 0003015876-2023-00291
• Device Sequence Number: 6327426
• Product Code: MLN
• UDI-Device Identifier: 00883873784938
• UDI-Public: 00883873784938
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/30/2023

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 Model Number: 11996
• Device Catalogue Number: 11996-000090
• Device Lot Number: 231500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2022
• 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: Female