MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® CR2 DEFIBRILLATOR; Automated External Defibrillators (Non-Wearable)

Model Number	CR2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.The customer informed stryker that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.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.
Event or Problem Description
The customer contacted stryker to report that their device's electrode's did not deploy as expected and could not be used to defibrillate a patient.Another aed was used after a delay.The patient involved in the event did not survive.It is not known if this event caused or contributed to their death.
Additional Manufacturer Narrative
The device was returned to stryker's product access center (pac) for evaluation.The pac was able to verify the reported issue and determined the electrode pads were not removed correctly during the event.The cause of the reported issue was determined to be use error.A clinical review was performed and here was inadequate contextual information from the reported event and t is unknown if the device caused or contributed to the reported outcome.
Event or Problem Description
The customer contacted stryker to report that their device's electrode's did not deploy as expected and could not be used to defibrillate a patient.Another aed was used after a delay.The patient involved in the event did not survive.It is not known if this event caused or contributed to their death.
Event or Problem Description
The customer contacted stryker to report that their device's electrode's did not deploy as expected and could not be used to defibrillate a patient.Another aed was used after a delay.The patient involved in the event did not survive.It is not known if this event caused or contributed to their death.
Additional Manufacturer Narrative
B1/h1 have been updated.

• Brand Name: LIFEPAK® CR2 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: juan salazar ; 11811 willows road ne; redmond, WA 98052 ; +1(425)867-4000
• MDR Report Key: 18615768
• Report Number: 0003015876-2024-00220
• Device Sequence Number: 7508925
• Product Code: MKJ
• UDI-Device Identifier: 00883873867808
• UDI-Public: 00883873867808
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P170018
• 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): 09/24/2026

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: Lay User/Patient
• Device Model Number: CR2
• Device Catalogue Number: 11101-000021
• Device Lot Number: 50694419
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/04/2024; 08/26/2026
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 04/10/2024; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 81 YR
• Patient Sex: Male
• Patient Race: White