MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 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	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker evaluated the customer's device and confirmed the reported issue.The root cause of the issue was isolated to the reed switch sw5.The customer received a replacement device.
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.During evaluation it was found that the device would intermittently power on.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.

• 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18636703
• Report Number: 0003015876-2024-00239
• Device Sequence Number: 7731746
• Product Code: MKJ
• UDI-Device Identifier: 00883873824078
• UDI-Public: 00883873824078
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2024

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: 99512-001267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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