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 Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has been provided with a replacement device.Stryker evaluated the customer's device and verified the reported issue.It was 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.
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 associated with the reported event.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and verified the reported issue.It was 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 associated with 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16250693
• Report Number: 0003015876-2023-00142
• Device Sequence Number: 6562554
• Product Code: MKJ
• UDI-Device Identifier: 00883873824085
• UDI-Public: 00883873824085
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/22/2023

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: 99512-001266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 03/19/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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 Sex: Unknown