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

Model Number	LIFEPAK 35
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The (b)(6) fire department is writing to formally express our serious concerns regarding the performance and reliability of the stryker lp35 monitors recently deployed within our organization.These monitors are essential to the delivery of emergency medical services, and the repeated failures we have experienced have compromised both operational readiness and patient safety.Upon initiating training with the lp35 monitors in april, we immediately encountered problems with faulty pulse oximetry (spo2) cables, all of which required replacement.Beginning in may, additional and more significant failures were observed across multiple units, including the inability to accurately read cardiac rhythms when connected to patients.To date, at least six (6) lp35 monitors have demonstrated this critical malfunction.Despite repeated service interventions, including replacement of leads and inspection by stryker technicians, the monitors continue to fail.This has left our department in the unacceptable position of relying on medical devices that do not consistently function as intended.As of this letter, no effective resolution or long-term corrective action has been provided by stryker.We can provide further documentation/details upon request.Pt code: 4582.Device code: 1535.Reference reports: mw5176382, mw5176383, mw5176384, mw5176385, mw5176386.

• Brand Name: SRTYKER LIFEPAK 35
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): STRYKER /PHYSIO-CONTROL, INC.; bloomington IL 61701
• MDR Report Key: 23123859
• Report Number: MW5176387
• Device Sequence Number: 20374928
• Product Code: MKJ
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LIFEPAK 35
• 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: 09/22/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown