FDA Adverse Event Death Summary report: N

LIFEPAK 35 MONITOR/DEFIBRILLATOR

MDR report key: 24363972 · Received February 17, 2026

Report

Report Number
MW5183865
Event Type
Death
Date Received
February 17, 2026
Date of Event
January 6, 2026
Report Date
February 7, 2026
Manufacturer
STRYKER / PHYSIO-CONTROL, INC.
Product Code
MKJ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
DE, US
Reporter Occupation
501
Health Professional
Yes

Narratives

Description of Event or Problem · 0

ON (B)(6) 2026, A PARAMEDIC UNIT WAS RESPONDING TO A PUBLIC LOCATION FOR A REPORTED CARDIAC ARREST. THE PARAMEDIC UNIT, STAFFED WITH A SINGLE PARAMEDIC PROVIDER IN A "CHASE UNIT" STYLE VEHICLE ARRIVED ON SCENE AT 08:45:03 AT THE SAME TIME AS A TROOPER WITH DELAWARE STATE POLICE. UPON MAKING PATIENT CONTACT, THE PARAMEDIC AND THE STATE TROOPER REMOVED THE PATIENT FROM THE DRIVERS SEAT OF HIS VEHICLE. THE PARAMEDIC THEN TURNED ON THE CARDIAC MONITOR AND APPLIED THE PRE-CONNECTED THERAPY PADS AT 08:46:42. THE PADS WERE APPLIED TO THE PATIENT'S BARE CHEST IN THE STANDARD ORIENTATION BASED ON MANUFACTURER RECOMMENDATION AND AS SHOWN ON THE THERAPY PAD ILLUSTRATION. THE INITIAL RHYTHM AT 08:46:44 WAS IDENTIFIED TO BE VENTRICULAR FIBRILLATION AND THE PARAMEDIC CHARGED THE MONITOR WITH A COMPLETED CHARGE AT 08:46:54. A MANUAL SHOCK OF 360J WAS DELIVERED AT 08:47:05. SUBSEQUENT MESSAGES RELATING TO THE THERAPY PADS BEING OFF AND THEN ON BEGAN AT 08:49:04. THE PROVIDER ATTEMPTED TO PRESS THE CHARGE BUTTON THREE TIMES BEFORE A "CHARGING" MESSAGE WAS DISPLAYED AT 08:49:44. LESS THAN 10 SECONDS FOLLOWING THE "CHARGING" MESSAGE WAS SEEN, THE ENERGY WAS CANCELED AT 08:49:44. THE PROVIDER ATTEMPTED TO CHARGE AGAIN AT 08:50:01, WITH A CHARGE COMPLETED AT 08:50:09 AND THE ENERGY CANCELED AT 08:50:15. THIS WOULD HAPPEN ANOTHER FIFTEEN TIMES (15) WITH THE LAST ATTEMPT TO CHARGE THE MONITOR WITH A SUBSEQUENT "ENERGY CANCELED" AT 09:27:20 WHEN THE PATIENT ARRIVING AT THE EMERGENCY DEPARTMENT. REVIEWING THE PATIENT CARE REPORT AND THE DATA PROVIDED FROM THE MONITOR, THE PATIENT WOULD REMAIN IN VENTRICULAR FIBRILLATION THROUGH THE ENTIRETY OF THE PATIENT CONTACT UP TO TRANSFER OF CARE IN THE EMERGENCY DEPARTMENT AT 09:30. THROUGH THE COURSE OF AN INTERNAL INVESTIGATION, BODY WORN CAMERA (BWC) FOOTAGE WAS ABLE TO BE SEEN, BUT NOT DOWNLOADED DUE TO THE LACK OF A SUBPOENA AND/OR A FORMAL INVESTIGATION FROM AN OUTSIDE ENTITY. VIEWING THE FOOTAGE SHOWED CLEAR EVIDENCE THAT THE MONITOR WAS UNABLE TO DELIVER A SHOCK WHEN MEDICALLY INDICATED. THE VIDEO WOULD SHOW THE PROVIDERS ATTEMPTING MULTIPLE TIMES TO CHARGE THE MONITOR AND THEN BE SHOWN A "ENERGY CANCELED" MESSAGE. THE TIMES WHEN A CHARGE WAS COMPLETE, THE PROVIDER CAN BE SEEN IN THE BWC FOOTAGE ATTEMPTING TO PUSH THE "SHOCK" BUTTON MULTIPLE TIMES WITHOUT SUCCESS. THE MONITOR WAS TESTED WITH THE MANUFACTURER PROVIDED THERAPY TESTING DEVICE AS WELL AS IT WAS EVALUATED BY THE PRODUCTS SERVICE TECHNICIAN SHOWING NO ABNORMALITIES TO THE FUNCTIONALITY OF THE CARDIAC MONITOR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
422064 LIFEPAK 35 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ STRYKER / PHYSIO-CONTROL, INC.

Patients

Seq Age Sex Outcome Treatment
1 50 YR Male Death