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

Model Number	CR2
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker performed an initial evaluation of the customer¿s device and verified the device was unable to power on when the lid was opened.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 a non-critical issue with their device.Upon evaluation of the customer¿s device, stryker observed that the device would not power on when the device lid was activated.In this state defibrillation therapy may be delayed if needed or may lead to use error resulting in a failure to deliver defibrillation.There was no patient use reported with the event.
Additional Manufacturer Narrative
Stryker further evaluated the customer's device and observed that the device was able to power on using the on/off button.Stryker determined that the cause of the reported issue was due to the lid switch, designator sw5.Stryker archived the device.The customer received a replacement device.
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.Upon evaluation of the customer¿s device, stryker observed that the device would not power on when the device lid was activated.In this state defibrillation therapy may be delayed if needed or may lead to use error resulting in a failure to deliver defibrillation.There was no patient use reported with the 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: 19838118
• Report Number: 0003015876-2024-02295
• Device Sequence Number: 15395924
• Product Code: MKJ
• UDI-Device Identifier: 00883873824061
• UDI-Public: 00883873824061
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 08/14/2024

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: 99512-001268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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 Sex: Unknown