MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 35 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	35
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Septic Shock (2068)
Date of Event	08/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Stryker evaluated the customer's device and duplicated the reported issue.Stryker determined a faulty nibp module was the cause of the reported issue.The module was replaced, proper device operation was observed through functional and performance testing and the device was returned to the customer for use.Stryker performed a clinical review of the reported event and determined that the device use may have contributed to the patient outcome.Stryker contacted the customer to request additional information on the patient.Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.
Event or Problem Description
The customer contacted stryker to report that their device gave high but inaccurate blood pressure values while treating the patient for septic shock.The customer stated that had the readings been accurate, they would have provided proper treatment during transport.The patient required treatment in the icu before ultimately recovering and being discharged.
Event or Problem Description
The customer contacted stryker to report that their device gave high but inaccurate blood pressure values while treating the patient for septic shock.The customer stated that had the readings been accurate, they would have provided proper treatment during transport.The patient required treatment in the icu before ultimately recovering and being discharged.
Additional Manufacturer Narrative
During the initial evaluation of the customer¿s lp35 by the stryker service technician, the non-invasive blood pressure (nibp) readings were observed to be above the expected tolerance.No other failure of the device was observed.The nibp module was removed from the device and forwarded to the stryker product assessment center (pac) for further evaluation.The device was repaired, the nibp module was replaced as a precaution, and the device was returned to the customer for use.As part our review and investigation, the stryker medical redmond product analysis center (pac) evaluated and reported that the values seen by the service technician could not be reproduced during testing.The pac technician retested with the same calibrated tool used by the service technician and could not duplicate any problem with the module.To further assess the module, it was forwarded to the supplier, suntech, for additional testing and evaluation.Suntech reported that the module passed all testing and met specifications.There was no confirmed failure of the module.Additionally, the nibp measurement data from the lp35 was also reviewed by a quality engineer.The files verified that the values taken during transit were higher than those reported at the departing and arriving facilities.There was also an indication on two of the nibp measurements that the cuff size used was too tight or too small of a cuff was used for measurement.The combination of transport motion artifact, patient muscle movement, and tight application of the cuff during this case are likely contributors to the high nibp readings.There is no conclusive evidence of a device malfunction considering the direct impact of these factors on the oscillometric measurements performed by the device.Stryker also conducted a clinical review of the complaint.The patient, exhibiting septic shock, had low blood pressure confirmed at facility a.During transport, nibp readings from the lp35 device were inconsistent with clinical symptoms and prior measurements.Alternative blood pressure methods were used but not factored into care decisions.Upon arrival at facility b, the patient required immediate intervention and was later discharged.Unforeseeable user error was determined as the primary cause of the patient's condition.

• Brand Name: LIFEPAK 35 MONITOR/DEFIBRILLATOR
• 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: 23091174
• Report Number: 0003015876-2025-01932
• Device Sequence Number: 12797453
• Product Code: MKJ
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 03/04/2026

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: 35
• Device Catalogue Number: 99335-000031
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 81 KG