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

Model Number	11103
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	02/15/2023
Type of Reportable Event	Death
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.The customer provided stryker with the available patient information.
Event or Problem Description
The customer contacted stryker to report that their device would not recognize the electrodes when applied to the patient.In this state the device may not be able to deliver defibrillation therapy if needed.The electrodes were immediately removed and replaced with another device's electrodes.Asystole was detected with the second device.The patient associated with the reported event did not survive.There has been no alleged device contribution to the patient outcome.
Additional Manufacturer Narrative
The device nor the electrodes were returned for investigation.The cause of the reported issue could not be determined.H3 other text : device not returned to manufacturer.
Event or Problem Description
The customer contacted stryker to report that their device would not recognize the electrodes when applied to the patient.In this state the device may not be able to deliver defibrillation therapy if needed.The electrodes were immediately removed and replaced with another device's electrodes.Asystole was detected with the second device.The patient associated with the reported event did not survive.There has been no alleged device contribution to the patient outcome.

• Brand Name: QUIK 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16542050
• Report Number: 0003015876-2023-00478
• Device Sequence Number: 15083201
• Product Code: DRX
• UDI-Device Identifier: 00883873871577
• UDI-Public: 00883873871577
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K943301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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: Lay User/Patient
• Device Model Number: 11103
• Device Catalogue Number: 11103-000026
• Device Lot Number: 220117-3693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• 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 CR PLUS DEFIBRILLATOR, MKJ SN (B)(6).
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female