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

Model Number	CRPLUS
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A clinical review was performed through review of the software log and it could not be determined if use of the device caused or contributed to the patient outcome.Stryker continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.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 informed stryker that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.
Event or Problem Description
The customer reported a patient death after use of the device.The customer was unsure if the device delivered defibrillation as intended.
Event or Problem Description
The customer reported a patient death after use of the device.The customer was unsure if the device delivered defibrillation as intended.
Additional Manufacturer Narrative
Stryker was unable to determine if the device experienced issues, it was not made available for evaluation; however further information was received and the clinical review was done again.The customer reported the patient event of cardiac arrest was not witnessed and the patient was found with a laceration to the head with blood coagulating on the ground.Delay to defibrillation reduces the patient's chance of survival.This indicates the device did not cause or contribute to the patient outcome.
Additional Manufacturer Narrative
Stryker was able to access the device and software logs.The software logs contained no data for the date of the event therefore no cause for the reported event could be determined.This device is past it's serviceable life and was archived by the customer.The customer received a replacement device.
Event or Problem Description
The customer reported a patient death after use of the device.The customer was unsure if the device delivered defibrillation as intended.

• Brand Name: LIFEPAK CRPLUS 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: 23357371
• Report Number: 0003015876-2025-02192
• Device Sequence Number: 18358080
• Product Code: MKJ
• UDI-Device Identifier: 00883873820292
• UDI-Public: 00883873820292
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K033275
• 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): 03/26/2026

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: Lay User/Patient
• Device Model Number: CRPLUS
• Device Catalogue Number: 99403-000110
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 10/24/2025; 02/27/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/21/2025; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2006
• 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