MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) CR2 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	CR2
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.The customer will receive a replacement device.Stryker continues to investigate the reported issue 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 delivered autonomously shock when users were performing cpr.In this state, wrong defibrillation therapy may be delivered.There were no adverse consequences to the patient as a result of the reported event.
Event or Problem Description
The customer contacted stryker to report that their device automatically delivered shock to the patient even though the patient was awake with stabile vital signs.There were no adverse consequences to the patient as a result of the reported event.
Additional Manufacturer Narrative
Executive summary of initial mdr indicates: the customer contacted stryker to report that their device delivered autonomously shock when users were performing cpr.In this state, wrong defibrillation therapy may be delivered.There were no adverse consequences to the patient as a result of the reported event.Executive summary of initial mdr should indicate: the customer contacted stryker to report that their device automatically delivered shock to the patient even though the patient was awake with stabile vital signs.There were no adverse consequences to the patient as a result of the reported event.
Additional Manufacturer Narrative
The product assessment center (pac) technician evaluated the customer's device and was not able to verify the reported issue.A root cause of the reported issue could not be determined.The device was archived by stryker.Section a4 weight units of initial mdr indicates: kilogram(s).Section a4 weight units of initial mdr should indicate: pounds.
Event or Problem Description
The customer contacted stryker to report that their device automatically delivered shock to the patient even though the patient was awake with stabile vital signs.There were no adverse consequences to the patient as a result of the reported event.

• Brand Name: LIFEPAK(R) 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 19218279
• Report Number: 0003015876-2024-01385
• Device Sequence Number: 20575276
• Product Code: MKJ
• UDI-Device Identifier: 00883873824115
• UDI-Public: 00883873824115
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/23/2024

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: Lay User/Patient
• Device Model Number: CR2
• Device Catalogue Number: 99512-001263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 05/21/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 05/16/2024; 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2021
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White