MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	20E
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.Clinical review was performed for the reported event: device use error may have contributed to the patient outcome.Reviewing the patient's electronic data (pco file), it emerged that the user pressed the shock button 52 seconds after that the device was charged, resulting in a delay of 52 seconds for therapy.In the medical judgment of these reviewers, the device use may have contributed to the reported outcome.A stryker service representative performed an evaluation of the customer¿s device and was not able to duplicate the reported issue.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.
Event or Problem Description
The customer contacted stryker to report that their device delivered autonomously shock without users pressing the shock button.In this state, wrong defibrillation therapy may be delivered.The patient associated with the reported event did not survive.
Additional Manufacturer Narrative
The electronic records were downloaded for investigation.The issue was not able to be verified.The cause of the reported issue was determined to be user error.
Event or Problem Description
The customer contacted stryker to report that their device delivered autonomously shock without users pressing the shock button.In this state, wrong defibrillation therapy may be delivered.The patient associated with the reported event did not survive.
Additional Manufacturer Narrative
Section b1, adverse event/product problem, has been corrected.Section h11, additional mfg narrative should indicate: the downloaded electronic records were reviewed by a customer quality engineer (cqe).The review confirmed the device powered on normally, electrodes were connected, and analysis was initiated.The device appropriately determined a shockable rhythm and charged, advising a shock.Cardiopulmonary resuscitation (cpr) continued for approximately 52 seconds after the initial "shock advised" prompt.An additional press of the analyze button did not initiate a new analysis, as analysis had already been completed and no shock had yet been delivered.The device remained charged in the "shock advised" state.The logs show the shock button was pressed one second after the device re-advised a shock, resulting in delivery of a 200 joules shock.Cpr stopped concurrently with shock delivery.Based on review of available information, no device malfunction or performance issue was identified.The device functioned as designed and in accordance with specifications.The event was attributed to use error.Per the device operating instructions, users are instructed to ensure all individuals are clear of the patient prior to pressing the shock button.
Event or Problem Description
The customer contacted stryker to report that their device delivered autonomously shock without users pressing the shock button.In this state, wrong defibrillation therapy may be delivered.The patient associated with the reported event did not survive.

• Brand Name: LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• 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: 18710878
• Report Number: 0003015876-2024-00339
• Device Sequence Number: 15495166
• Product Code: MKJ
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2026

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 Model Number: 20E
• Device Catalogue Number: 99507-000133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 04/23/2024; 04/09/2026
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 04/23/2024; 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2019
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male