MAUDE Adverse Event Report: STRYKER / PHYSIO-CONTROL, INC. LIFEPAK 35 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number	99335-000031
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a paramedic crew made up of a 3 person crew arrived on scene of a suspected cardiac arrest.The patient had to be extricated from their garage and the crews prepared to begin treatment in the driveway.Upon making patient contact, the crew began manual compressions and attached the patient to the lifepak 35 cardiac monitor/defibrillator at approximately 06:55hrs.The crew initially attached the patient to the therapy pads that were pre-connected to the therapy cable of the lifepak 35.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.Once applied, the crew went to determine a tracing/rhythm to find that no tracings were detected.During the initial internal investigation, brief footage was forwarded to the investigation team and the same as reported was seen.Within the video, the crew can be heard dictating that the therapy cable was plugged into the top of the monitor and secured, the pads were connected to the therapy cable, and the pads were applied to the patient correctly.At no time did the crew appreciate a message of "pads disconnected" or "therapy pads disconnected".Similar events with those messages have been reported to our office with subsequent reports made to the fda due to the failure in being able to obtain a tracing on the cardiac monitor.The crew attempted to change the therapy pads while leaving the patient on the lifepak 35.No change was appreciated and no tracing was obtained.The crew attempted to push harder on the therapy pads in attempts to see if there was a connectivity issue with the pads.Pressing down on the pads showed no change.The crew then pivoted to an available lifepak 15 at 06:57, where they would continue patient care until transfer of care was done at the emergency department at approximately 07:58.The crew saved the therapy pads that were used with the lifepak 35 with intentions to send the pads back to stryker for analysis.

• Brand Name: LIFEPAK 35 MONITOR/DEFIBRILLATOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): STRYKER / PHYSIO-CONTROL, INC.; redmond
• MDR Report Key: 24381080
• Report Number: MW5184040
• Device Sequence Number: 12865271
• Product Code: MKJ
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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 Catalogue Number: 99335-000031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White