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

Model Number 11103

Device Problem Failure to Sense (1559)

Patient Problem Asystole (4442)

Event Date 02/15/2023

Event Type  Death  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 311285659
• Report Number: 0003015876-2023-00478
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 00883873871577
• UDI-Public: 00883873871577
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K943301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LIFEPAK CR PLUS DEFIBRILLATOR, MKJ SN (B)(6).
• Patient Outcome(s): Death
• Patient Sex: Female