MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 35 MONITOR/DEFIBRILLATOR; Automated External Defibrillators (Non-Wearable)

Model Number	35
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Stryker performed a clinical review and it was 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.No response has been received from the customer.A stryker field service technician evaluated the customer's device and was unable to duplicate the reported issue.After performing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.
Event or Problem Description
A customer contacted stryker to report that their device lost ecg signal during monitoring of a cardiac event.The customer advised to remove and replace the pads, after which they were able to continue patient event.The patient associated with the reported event did not survive.
Event or Problem Description
A customer contacted stryker to report that their device lost ecg signal during monitoring of a cardiac event.The customer advised to remove and replace the pads, after which they were able to continue patient event.The patient associated with the reported event did not survive.
Additional Manufacturer Narrative
The following items have been corrected: b1: adverse event and product problem.H1: death.
Additional Manufacturer Narrative
The electrodes were returned for evaluation.Stryker product analysis center (pac) evaluated the electrode and was unable to duplicate and verify the reported issue.A clinical review was performed with the following results "it was identified that the user pressed the sync button, then the pacing button which automatically switched the lead view to lead ii.The user then starts the cpr timer, which activates cprinsight, and places the device back into defib mode.Given the evidence that the patient switched several times between a shockable and nonshockable rhythm, the patient may have been in a shockable rhythm during the 4 minutes and 46 seconds in which an ecg tracing was not available, and cprinsight did not complete an analysis.As a result, it is possible that the provider missed providing a shock to the patient during this time, which may have contributed to the patient¿s outcome." a stryker software engineer reviewed the electronic patient records and verified the reported issue was a result of unintentionally changing the displayed waveform.It was determined that the cause of the issue was use error.
Event or Problem Description
A customer contacted stryker to report that their device lost ecg signal during monitoring of a cardiac event.The customer advised to remove and replace the pads, after which they were able to continue patient event.The patient associated with the reported event did not survive.

• 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 ; +1(425)867-4000
• MDR Report Key: 23850496
• Report Number: 0003015876-2025-02712
• Device Sequence Number: 18523478
• Product Code: MKJ
• UDI-Device Identifier: 00883873765586
• UDI-Public: 00883873765586
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• 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): 08/10/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 35
• Device Catalogue Number: 99335-000032
• Date Returned to Manufacturer: 11/25/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 04/08/2026; 07/28/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 04/30/2026; 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• 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: Unknown